Publications by authors named "David G Armstrong"

372 Publications

The amputation and mortality of inpatients with diabetic foot ulceration in the COVID-19 pandemic and postpandemic era: A machine learning study.

Int Wound J 2021 Nov 24. Epub 2021 Nov 24.

Department of Endocrinology, School of Medicine, Bioengineering College, Chongqing Emergency Medical Center, Chongqing University Central Hospital, Chongqing University, Chongqing, China.

This study aimed to explore the clinical characteristic and outcomes of inpatients with diabetic foot ulceration (DFU) in 2019 (prelockdown) and 2020 (postlockdown) due to the COVID-19 pandemic, at an emergency medical service unit. Prediction models for mortality and amputation were developed to describe the risk factors using a machine learning-based approach. Hospitalized DFU patients (N = 23) were recruited after the lockdown in 2020 and matched with corresponding inpatients (N = 23) before lockdown in 2019. Six widely used machine learning models were built and internally validated using 3-fold cross-validation to predict the risk of amputation and death in DFU inpatients under the COVID-19 pandemic. Previous DF ulcers, prehospital delay, and mortality were significantly higher in 2020 compared to 2019. Diabetic foot patients in 2020 had higher hs-CRP levels (P = .037) but lower hemoglobin levels (P = .017). The extreme gradient boosting (XGBoost) performed best in all models for predicting amputation and mortality with the highest area under the curve (0.86 and 0.94), accuracy (0.80 and 0.90), sensitivity (0.67 and 1.00), and negative predictive value (0.86 and 1.00). A long delay in admission and a higher risk of mortality was observed in patients with DFU who attended the emergency center during the COVID-19 post lockdown. The XGBoost model can provide evidence-based risk information for patients with DFU regarding their amputation and mortality. The prediction models would benefit DFU patients during the COVID-19 pandemic.
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http://dx.doi.org/10.1111/iwj.13723DOI Listing
November 2021

Initial Clinical Experience With a Simple, Home System for Early Detection and Monitoring of Diabetic Foot Ulcers: The Foot Selfie.

J Diabetes Sci Technol 2021 Oct 31:19322968211053348. Epub 2021 Oct 31.

Department of Surgery, Southwestern Academic Limb Salvage Alliance, Keck School of Medicine of University of Southern California, Los Angeles, CA, USA.

Background: Diabetic foot ulcers (DFUs) are a leading cause of disability and morbidity. There is an unmet need for a simple, practical, home method to detect DFUs early and remotely monitor their healing.

Method: We developed a simple, inexpensive, smartphone-based, "" system that enables patients to photograph the plantar surface of their feet without assistance and transmit images to a remote server. In a pilot study, patients from a limb-salvage clinic were asked to image their feet daily for six months and to evaluate the system by questionnaire at five time points. Transmitted results were reviewed weekly.

Results: Fifteen patients (10 male) used the system after approximately 5 minutes of instruction. Participants uploaded images on a median of 76% of eligible study days. The system captured and transmitted diagnostic quality images of the entire plantar surface of both feet, permitting clinical-management decisions on a remote basis. We monitored 12 active wounds and 39 pre-ulcerative lesions (five wounds and 13 pre-ulcerative lesions at study outset); we observed healing of seven wounds and reversal of 20 pre-ulcerative lesions. Participants rated the system as useful, empowering, and preferable to their previous methods of foot screening.

Conclusions: With minimal training, patients transmitted diagnostic-quality images from home on most days, allowing clinicians to review serial images. This system permits inexpensive home foot screening and monitoring of DFUs. Further studies are needed to determine whether it can reduce morbidity of DFUs and/or the associated cost of care. Artificial intelligence integration could improve scalability.
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http://dx.doi.org/10.1177/19322968211053348DOI Listing
October 2021

Nontouch Infrared Skin Thermometry: An Underutilized Tool.

Adv Skin Wound Care 2021 Nov;34(11):614-615

R. Gary Sibbald, MD, MEd, BSc, FRCPC (Med Derm), MACP, FAAD, MAPWCA, DSc (Hons), is Professor of Public Health and Medicine, University of Toronto, Ontario, Canada; Director, International Interprofessional Wound Care Course & Masters of Science in Community Health (Prevention & Wound Care), Dalla Lana School of Public Health, University of Toronto; Past President, Chair Education Committee, World Union of Wound Healing Societies; and Editor-in-Chief, Advances in Skin & Wound Care. Asfandyar Mufti, MD, BMSc, is Dermatology Resident, Faculty of Medicine, University of Toronto. David G. Armstrong, MD, PhD, DPM, is Professor of Surgery, University of Arizona College of Medicine, Tucson; and Director, Southern Arizona Limb Salvage Alliance. Hiske Smart, MA (Nur), RN, PGDipWHTR (UK), IIWCC, is Manager, Wound Care & Hyperbaric Oxygen Therapy Unit, King Hamad University Hospital, Kingdom of Bahrain.

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http://dx.doi.org/10.1097/01.ASW.0000795248.80980.89DOI Listing
November 2021

Time in range in relation to amputation and all-cause mortality in hospitalised patients with diabetic foot ulcers.

Diabetes Metab Res Rev 2021 Sep 29:e3498. Epub 2021 Sep 29.

Department of Endocrinology, College of Medicine, College of Bioengineering, Chongqing Emergency Medical Center, Chongqing University Central Hospital, Chongqing University, Chongqing, China.

Aims: The aim of this study was to evaluate the association of time in range (TIR) with amputation and all-cause mortality in hospitalised patients with diabetic foot ulcers (DFUs).

Materials And Methods: A retrospective analysis was performed on 303 hospitalised patients with DFUs. During hospitalisation, TIR, mean blood glucose (MBG), coefficient of variation (CV), time above range (TAR) and time below range (TBR) of patients were determined from seven-point blood glucose profiles. Participants were grouped based on their clinical outcomes (i.e., amputation and death). Logistic regression was employed to analyse the association of TIR with amputation and all-cause mortality of inpatients with DFUs.

Results: Among the 303 enrolled patients, 50 (16.5%) had undergone amputation whereas seven (2.3%) were deceased. Blood glucose was determined in 41,012 samples obtained from all participants. Patients who underwent amputation had significantly lower TIR and higher MBG, CV, level 2 TAR and level 1 TBR whereas deceased patients had significantly lower TIR and higher MBG and level 2 TAR. Both amputation and all-cause mortality rate declined with an increase in TIR quartiles. Logistic regression showed association of TIR with amputation (p = 0.034) and all-cause mortality (p = 0.013) after controlling for 15 confounders. This association was similarly significant in all-cause mortality after further adjustment for CV (p = 0.022) and level 1 TBR (p = 0.021), respectively.

Conclusions: TIR is inversely associated with amputation and all-cause mortality of hospitalised patients with DFUs. Further prospective studies are warranted to establish a causal relationship between TIR and clinical outcomes in patients with DFUs.
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http://dx.doi.org/10.1002/dmrr.3498DOI Listing
September 2021

Staged salvage of diabetic foot with Chopart amputation and intramedullary nailing.

SAGE Open Med Case Rep 2021 16;9:2050313X211046732. Epub 2021 Sep 16.

Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

We present a stepwise surgical approach that can be used, in lieu of a transtibial amputation, to preserve the lower limb in the setting of severe diabetic foot infections. A 63-year-old male status post left midfoot (Lisfranc's) amputation presented to our hospital with a 4-year history of a left foot diabetic ulcer with associated purulent drainage and intermittent chills. On initial exam, the patient's left foot amputation stump was plantarflexed, grossly erythematous, and edematous. The associated diabetic foot ulcer was actively draining purulent fluid. Following workup with radiography and ultrasound, the patient was diagnosed with a post-operative infection of the midfoot at the level of the amputation stump secondary to diabetic neuropathy. Our approach to management was a staged and included (1) surgical irrigation and debridement of the distal stump wound, (2) provisional negative pressure therapy, (3) a second-look procedure, and (4) a tibiotalocalcaneal fusion was performed using a lateral transfibular and plantar approach, after wound closure and resolution of active infection was achieved. At 36-month follow-up, the patient was fully weight-bearing in stiff sole sneakers with no gross overt alteration of gait pattern. The patient scored 79 points when assessed by the hindfoot American Orthopaedic Foot and Ankle Society Ankle-Hindfoot outcome score. In the patient with diabetes and cardiological restrictions, a Chopart amputation is preferred due to the decreased level of energy expenditure required for ambulation as compared to over more proximal levels of amputation.
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http://dx.doi.org/10.1177/2050313X211046732DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8450981PMC
September 2021

An explainable machine learning model for predicting in-hospital amputation rate of patients with diabetic foot ulcer.

Int Wound J 2021 Sep 14. Epub 2021 Sep 14.

Department of Endocrinology and Metabolism, Chongqing Emergency Medical Center, Chongqing Key Laboratory of Emergency Medicine, Chongqing University Central Hospital, Chongqing University, Chongqing, China.

Diabetic foot ulcer (DFU) is one of the most serious and alarming diabetic complications, which often leads to high amputation rates in diabetic patients. Machine learning is a part of the field of artificial intelligence, which can automatically learn models from data and better inform clinical decision-making. We aimed to develop an accurate and explainable prediction model to estimate the risk of in-hospital amputation in patients with DFU. A total of 618 hospitalised patients with DFU were included in this study. The patients were divided into non-amputation, minor amputation or major amputation group. Light Gradient Boosting Machine (LightGBM) and 5-fold cross-validation tools were used to construct a multi-class classification model to predict the three outcomes of interest. In addition, we used the SHapley Additive exPlanations (SHAP) algorithm to interpret the predictions of the model. Our area under the receiver-operating-characteristic curve (AUC) demonstrated a 0.90, 0.85 and 0.86 predictive ability for non-amputation, minor amputation and major amputation outcomes, respectively. Taken together, our data demonstrated that the developed explainable machine learning model provided accurate estimates of the amputation rate in patients with DFU during hospitalisation. Besides, the model could inform individualised analyses of the patients' risk factors.
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http://dx.doi.org/10.1111/iwj.13691DOI Listing
September 2021

Improved healing of chronic diabetic foot wounds in a prospective randomised controlled multi-centre clinical trial with a microvascular tissue allograft.

Int Wound J 2021 Sep 1. Epub 2021 Sep 1.

The Angiogenesis Foundation, Cambridge, Massachusetts, USA.

This study assesses the impact of a processed microvascular tissue (PMVT) allograft on wound closure and healing in a prospective, single-blinded, multi-centre, randomised controlled clinical trial of 100 subjects with Wagner Grade 1 and 2 chronic neuropathic diabetic foot ulcerations. In addition to standard wound care, including standardised offloading, the treatment arm received PMVT while the control arm received a collagen alginate dressing. The primary endpoint was complete wound closure at 12 weeks. Secondary endpoints assessed on all subjects were percent wound area reduction, time to healing, and local neuropathy. Novel exploratory sub-studies were conducted for wound area perfusion and changes in regional neuropathy. Weekly application of PMVT resulted in increased complete wound closure at 12 weeks (74% vs 38%; P = .0003), greater percent wound area reduction from weeks four through 12 (76% vs 24%; P = .009), decreased time to healing (54 days vs 64 days; P = .009), and improved local neuropathy (118% vs 11%; P = .028) compared with the control arm. Enhanced perfusion and improved regional neuropathy were demonstrated in the sub-studies. In conclusion, this study demonstrated increased complete healing with PMVT and supports its use in treating non-healing DFUs. The observed benefit of PMVT on the exploratory regional neuropathy and perfusion endpoints warrants further study.
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http://dx.doi.org/10.1111/iwj.13679DOI Listing
September 2021

A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers.

Int Wound J 2021 Aug 21. Epub 2021 Aug 21.

Professional Education and Research Institute, Roanoke, Virginia, USA.

Diabetic foot ulcers (DFUs) are at risk for detrimental complications even with current, standard of care (SOC) treatments. The primary objective of this randomised controlled trial was to compare a unique resorbable glass microfiber matrix (Mirragen; Advanced Wound Matrix [BBGFM]; ETS Wound Care, Rolla, Missouri) compared with a standard of care group (SOC, collagen alginate dressing) at 12 weeks. Both groups received standard diabetic foot care including glucose monitoring, weekly debridements when needed and an offloading device. The primary endpoint was proportion of full-thickness, non-infected, non-ischaemic wounds healed at 12 weeks, with secondary endpoints including percent area reduction (PAR) and changes in Semmes-Weinstein monofilament testing. The result illustrated in the intent-to-treat analysis at 12 weeks showed that 70% (14/20) of the BBGFM-treated DFUs healed compared with 25% (5/20) treated with SOC alone (adjusted P = .006). Mean PAR at 12 weeks was 79% in the BBGFM group compared with 37% in the SOC group (adjusted P = .027). Mean change in neuropathic score between baseline and up to 12 weeks of treatment was 2.0 in the BBGFM group compared with -0.6 in the SOC group where positive improvement in scores are better (adjusted P = .008). The mean number of BBGFM applications was 6.0. In conclusion, adding BBGFM to SOC significantly improved wound healing with no adverse events related to treatment compared with SOC alone.
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http://dx.doi.org/10.1111/iwj.13675DOI Listing
August 2021

Opportunities for diabetes and peripheral artery disease-related lower limb amputation prevention in an Appalachian state: A longitudinal analysis.

Prev Med Rep 2021 Sep 23;23:101505. Epub 2021 Jul 23.

West Virginia University School of Medicine, Department of Cardiovascular and Thoracic Surgery, Division of Vascular and Endovascular Surgery, United States.

Lower extremity amputation due to peripheral artery disease (PAD) and diabetes (DM) is a life-altering event that identifies disparities in access to healthcare and management of disease. West Virginia (WV), a highly rural state, is an ideal location to study these disparities. The WVU longitudinal health system database was used to identify 1) risk factors for amputation, 2) how disease management affects the risk of amputation, and 3) whether the event of amputation is associated with a change in HbA1c and LDL levels. Adults (≥18 years) with diagnoses of DM and/or PAD between 2011 and 2016 were analyzed. Multivariable logistic regression analyses were performed on patients with lab information for both HbA1c and LDL while adjusting for patient factors to examine associations with amputations. In patients who underwent amputation, we compared laboratory values before and after using Wilcoxon signed rank tests. 50,276 patients were evaluated, 369 (7.3/1000) underwent amputation. On multivariable analyses, Male sex and Self-pay insurance had higher odds for amputation. Compared to patients with DM alone, PAD patients had 12.3 times higher odds of amputation, while patients with DM and PAD had 51.8 times higher odds of amputation compared to DM alone. We found significant associations between odds of amputation and HbA1c (OR 1.31,CI = 1.15-1.48), but not LDL. Following amputation, we identified significant decreases in lab values for HbA1c and LDL. These findings highlight the importance of medical optimization and patient education and suggest that an amputation event may provide an important opportunity for changes in disease management and patient behavior.
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http://dx.doi.org/10.1016/j.pmedr.2021.101505DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8339221PMC
September 2021

A Limb is a Peninsula- and No Clinician is an Island: Introducing the American Limb Preservation Society (ALPS).

Foot Ankle Surg (N Y) 2021 29;1(1). Epub 2021 Mar 29.

Department of Surgery, Keck School of Medicine of University of Southern California, 1510 San Pablo St, Health Sciences Campus, Los Angeles, CA 90033.

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http://dx.doi.org/10.1016/j.fastrc.2021.100005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8312703PMC
March 2021

Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015-2018).

J Wound Care 2021 Jul;30(Sup7):S5-S16

College of Podiatric Medicine, Western University of Health Sciences, US.

Objective: To evaluate large propensity-matched cohorts to assess outcomes in patients receiving advanced treatment (AT) with skin substitutes for lower extremity diabetic ulcers (LEDUs) versus no AT (NAT) for the management of LEDUs.

Method: The Medicare Limited Dataset (1 October 2015 through 2 October 2018) were used to retrospectively analyse people receiving care for a LEDU treated with AT or NAT (propensity-matched Group 1). Analysis included major and minor amputations, emergency department (ED) visits and hospital readmissions. In addition, AT following parameters for use (FPFU) was compared with AT not FPFU (propensity-matched Group 2). A paired t-test was used for comparisons of the two groups. For comparisons of three groups, the Kruskal-Wallis test was used. A Bonferroni correction was performed when multiple comparisons were calculated.

Results: There were 9,738,760 patients with a diagnosis of diabetes, of whom 909,813 had a LEDU. In propensity-matched Group 1 (12,676 episodes per cohort), AT patients had statistically fewer minor amputations (p=0.0367), major amputations (p<0.0001), ED visits (p<0.0001), and readmissions (p<0.0001) compared with NAT patients. In propensity-matched Group 2 (1131 episodes per cohort), AT FPFU patients had fewer minor amputations (p=0.002) than those in the AT not FPFU group.

Conclusion: AT for the management of LEDUs was associated with significant reductions in major and minor amputation, ED use, and hospital readmission compared with LEDUs managed with NAT. Clinics should implement AT in accordance with the highlighted parameters for use to improve outcomes and reduce costs.
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http://dx.doi.org/10.12968/jowc.2021.30.Sup7.S5DOI Listing
July 2021

Stratification of Microvascular Disease Severity in the Foot Using Spatial Frequency Domain Imaging.

J Diabetes Sci Technol 2021 Jul 5:19322968211024666. Epub 2021 Jul 5.

The Division of Vascular Surgery, University of Arizona, Tucson, AZ, USA.

Background: Microvascular disease (MVD) describes systemic changes in the small vessels (~100 um diameter) that impair tissue oxygenation and perfusion. MVD is a common but poorly monitored complication of diabetes. Recent studies have demonstrated that MVD: (i) is an independent risk factor for ulceration and amputation and (ii) increases risk of adverse limb outcomes synergistically with PAD. Despite the clinical relevance of MVD, microvascular evaluation is not standard in a vascular assessment.

Methods: We evaluated 299 limbs from 153 patients seen clinically for possible lower extremity PAD. The patients were assessed by ankle brachial index (ABI), toe brachial index (TBI), and spatial frequency domain imaging (SFDI). These measurements were evaluated and compared to patient MVD status, defined by clinical diagnoses of (in ascending order of severity) no diabetes; diabetes; diabetes + neuropathy; diabetes + neuropathy + retinopathy.

Results: SFDI-derived parameters HbT1 and StO2 were significantly different across the MVD groups ( < .001). A logistic regression model based on HbT1 and StO2 differentiated limbs with severe MVD (diabetes+neuropathy+retinopathy) from the larger group of limbs from patients with only diabetes ( = .001, area under the curve = 0.844). Neither ABI nor TBI significantly differentiated these populations.

Conclusions: Standard assessment of PAD using ABI and TBI are inadequate for detecting MVD in at-risk populations. SFDI-defined HbT1 and StO2 are promising tools for evaluating MVD. Prospective studies with wound-based outcomes would be useful to further evaluate the role MVD assessment could play in routine clinical evaluation of patients at risk for lower extremity complications.
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http://dx.doi.org/10.1177/19322968211024666DOI Listing
July 2021

Molecular Biomarkers of Oxygen Therapy in Patients with Diabetic Foot Ulcers.

Biomolecules 2021 06 22;11(7). Epub 2021 Jun 22.

EO2 Concepts, San Antonio, TX 78249, USA.

Hyperbaric oxygen therapy (HBOT) and topical oxygen therapy (TOT) including continuous diffuse oxygen therapy (CDOT) are often utilized to enhance wound healing in patients with diabetic foot ulcerations. High pressure pure oxygen assists in the oxygenation of hypoxic wounds to increase perfusion. Although oxygen therapy provides wound healing benefits to some patients with diabetic foot ulcers, it is currently performed from clinical examination and imaging. Data suggest that oxygen therapy promotes wound healing via angiogenesis, the creation of new blood vessels. Molecular biomarkers relating to tissue inflammation, repair, and healing have been identified. Predictive biomarkers can be used to identify patients who will most likely benefit from this specialized treatment. In diabetic foot ulcerations, specifically, certain biomarkers have been linked to factors involving angiogenesis and inflammation, two crucial aspects of wound healing. In this review, the mechanism of how oxygen works in wound healing on a physiological basis, such as cell metabolism and growth factor signaling transduction is detailed. Additionally, observable clinical outcomes such as collagen formation, angiogenesis, respiratory burst and cell proliferation are described. The scientific evidence for the impact of oxygen on biomolecular pathways and its relationship to the outcomes in clinical research is discussed in this narrative review.
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http://dx.doi.org/10.3390/biom11070925DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8301753PMC
June 2021

Development and validation of a pocket guide for the prevention of diabetic foot ulcers.

Br J Nurs 2021 Jun;30(12):S6-S15

Associate Professor, Department of Nursing, Federal University of São Paulo, São Paulo, Brazil.

Objective: Diabetic foot ulcers can have serious consequences, including amputation. This project aimed to develop and validate a diabetes care management model-a pocket guide on the prevention of foot ulceration to assist health professionals and scientific societies.

Methods: An adaptation of the Iowa method of evidence-based practice to promote high-quality care was employed. After problems are identified, the Iowa method supports the development of an action plan for addressing them. An evidence-based protocol based on the five cornerstones of the 2015 guidance on the diabetic foot by the International Working Group on the Diabetic Foot was developed in two phases and validated using the Delphi technique.

Results: A model was developed to promote these five cornerstones, which are the main recommendations for managing the diabetic foot. These are: foot examination; risk assessment for ulceration; education in diabetes; appropriate footwear; and treatment of pre-ulcerative lesions. To adapt this into a health information document, the management model was synthesised and designed as a pocket guide. The model's individual and global content validity indices surpass 0.78 and 0.90 respectively.

Conclusion: A management model was created and validated, and produced as a pocket guide to deliver instructions on the care and prevention of diabetic foot problems in people with diabetes.
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http://dx.doi.org/10.12968/bjon.2021.30.12.S6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8382231PMC
June 2021

MRI nomenclature for musculoskeletal infection.

Skeletal Radiol 2021 Dec 18;50(12):2319-2347. Epub 2021 Jun 18.

Thomas Jefferson University Hospital, Philadelphia, PA, USA.

The Society of Skeletal Radiology (SSR) Practice Guidelines and Technical Standards Committee identified musculoskeletal infection as a White Paper topic, and selected a Committee, tasked with developing a consensus on nomenclature for MRI of musculoskeletal infection outside the spine. The objective of the White Paper was to critically assess the literature and propose standardized terminology for imaging findings of infection on MRI, in order to improve both communication with clinical colleagues and patient care.A definition was proposed for each term; debate followed, and the committee reached consensus. Potential controversies were raised, with formulated recommendations. The committee arrived at consensus definitions for cellulitis, soft tissue abscess, and necrotizing infection, while discouraging the nonspecific term phlegmon. For bone infection, the term osteitis is not useful; the panel recommends using terms that describe the likelihood of osteomyelitis in cases where definitive signal changes are lacking. The work was presented virtually to SSR members, who had the opportunity for review and modification prior to submission for publication.
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http://dx.doi.org/10.1007/s00256-021-03807-7DOI Listing
December 2021

Lower extremity reamputation in people with diabetes: a systematic review and meta-analysis.

BMJ Open Diabetes Res Care 2021 06;9(1)

Department of Surgery, USC Keck School of Medicine, Los Angeles, California, USA.

In this study, we determined the reamputation-free survival to both limbs and to the contralateral limb only following an index amputation of any-level and assessed whether reamputation rates have changed over time. We completed a systematic search using PubMed and screened a total of 205 articles for data on reamputation rates. We reported qualitative characteristics of 56 studies that included data on reamputation rates and completed a meta-analysis on 22 of the studies which enrolled exclusively participants with diabetes. The random-effects meta-analysis fit a parametric survival distribution to the data for reamputations to both limbs and to the contralateral limb only. We assessed whether there was a temporal trend in the reamputation rate using the Mann-Kendall test. Incidence rates were high for reamputation to both limbs and to the contralateral limb only. At 1 year, the reamputation rate for all contralateral and ipsilateral reamputations was found to be 19% (IQR=5.1%-31.6%), and at 5 years, it was found to be 37.1% (IQR=27.0%-47.2%). The contralateral reamputation rate at 5 years was found to be 20.5% (IQR=13.3%-27.2%). We found no evidence of a trend in the reamputation rates over more than two decades of literature analyzed. The incidence of lower extremity reamputation is high among patients with diabetes who have undergone initial amputations secondary to diabetes, and rates of reamputation have not changed over at least two decades.
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http://dx.doi.org/10.1136/bmjdrc-2021-002325DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8194332PMC
June 2021

Pain Management in People with Diabetes-Related Chronic Limb-Threatening Ischemia.

J Diabetes Res 2021 8;2021:6699292. Epub 2021 May 8.

Department of Rehabilitation, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan 646000, China.

Management of neuropathic pain in people with diabetes has been widely investigated. However, little attention was paid to address ischemic-related pain in patients with diabetes mellitus who suffered from chronic limb-threatening ischemia (CLTI), the end stage of lower extremity arterial disease (LEAD). Pain management has a tremendous influence on patients' quality of life and prognosis. Poor management of this type of pain owing to the lack of full understanding undermines patients' physical and mental quality of life, which often results in a grim prognosis, such as depression, myocardial infarction, lower limb amputation, and even mortality. In the present article, we review the current strategy in the pain management of diabetes-related CLTI. The endovascular therapy, pharmacological therapies, and other optional methods could be selected following comprehensive assessments to mitigate ischemic-related pain, in line with our current clinical practice. It is very important for clinicians and patients to strengthen the understanding and build intervention strategy in ischemic pain management and possible adverse consequence.
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http://dx.doi.org/10.1155/2021/6699292DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8128546PMC
May 2021

Functional Properties of a Purified Reconstituted Bilayer Matrix Design Support Natural Wound Healing Activities.

Plast Reconstr Surg Glob Open 2021 May 21;9(5):e3596. Epub 2021 May 21.

Professional Education and Research Institute, Roanoke, Va.

Biomaterial engineering has produced numerous matrices for use in tissue repair, utilizing various materials and processing methods, which can impact the ability of the products to encourage wound healing. Recently, we observed favorable clinical outcomes, using a novel purified reconstituted bilayer matrix (PRBM; Geistlich Derma-Gide) to treat chronic diabetic foot ulcers.

Methods: Evaluations of the structural and functional characteristics of PRBM in vitro were performed to assess how this biomaterial may affect the favorable clinical results observed by influencing the wound environment and key physiologic mechanisms necessary for the healing process. Investigations included scanning electron microscopy, cell culture analyses, gene expression assays, matrix metalloproteinase activity assessment, and pH measurement.

Results: Cross-sectional scanning electron microscopy demonstrated a distinct bilayer structure with porous and compact layers. The PRBM structure allowed cell types involved in wound healing to bind and proliferate. Expression analysis of growth factor-responsive genes demonstrated binding and preservation of bioactive growth factors TGF-β1, bFGF, and VEGF by PRBM. Boyden chamber migration assays revealed increased cellular migration compared with controls. In the presence of PRBM, the activity of MMP-1, MMP-2, and MMP-9 was significantly lower compared with control samples. pH of the PRBM in solution was slightly acidic.

Conclusions: Based on in vitro evaluations, it appears that the PRBM processing without deleterious chemical crosslinking results in a suitable ECM possessing characteristics to aid natural wound healing, including cell attachment, migration, proliferation, differentiation, and angiogenesis. These in vitro data support the promising healing rate observed clinically when chronic DFUs are treated with PRBM.
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http://dx.doi.org/10.1097/GOX.0000000000003596DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8140771PMC
May 2021

Comparison and Investigation of Exosomes Derived from Platelet-Rich Plasma Activated by Different Agonists.

Cell Transplant 2021 Jan-Dec;30:9636897211017833

The Key Laboratory of Laboratory Medical Diagnostics in the Ministry of Education and Department of Clinical Biochemistry, College of Laboratory Medicine, 12550Chongqing Medical University, Chongqing, China.

PRP-Exos are nanoscale cup-shaped vesicles that carry a variety of proteins, mRNAs, microRNAs, and other bioactive substances. PRP-Exos can be formed through several induction pathways, which determine their molecular profiles and facilitate their tailormade participation in intercellular communication. Currently, little is known on how the PRP-Exos activation method influences the quality and quantity of PRP-Exos. The present study aims to observe and analyze the number, profile, and growth factors of PRP-Exos through TEM, Nanoflow, and WB after PRP activation and compare the difference in function of PRP-Exos on HUVECs, with different stimuli (calcium gluconate, thrombin, or both). We found that PRP activated with both thrombin and calcium gluconate harvested the highest concentration of exosomes [(7.16 ± 0.46) × 10 particles/ml], compared to thrombin group [(4.87 ± 0.15) × 10 particles/ml], calcium gluconate group [(5.85 ± 0.43) × 10 particles/ml], or saline group [(7.52 ± 0.19) × 10 particles/ml], respectively ( < 0.05) via Nanoflow analysis. The WB analysis showed that cytokines (VEGF, PDGFBB, bFGF, TGF-β) are differentially encapsulated in PRP-Exos, depending on the PRP stimulus, in which the mixture-PRP-Exos yielded the highest concentration of cytokines. In the function assay of PRP-Exos on HUVECs, the mixture-PRP-Exos promoted HUVECs proliferation, increased HUVECs migration, promoted the formation of vessel-like by HUVECs via the AKT ERK signal pathway more dramatically, compared with other groups. In summary, our studies showed that PRP activated by the mixture of calcium gluconate and thrombin harvested the best quality of exosomes which had the top biological functions. This study provides a protocol for selecting appropriate PRP activators to obtain high-quality exosomes for future applications.
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http://dx.doi.org/10.1177/09636897211017833DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8138303PMC
May 2021

Stage 0 Charcot Neuroarthropathy in the Diabetic Foot: An Emerging Narrow Window of Opportunity?

Int J Low Extrem Wounds 2021 May 7:15347346211011844. Epub 2021 May 7.

8948King's College Hospital, London, UK.

In a world where popular culture and concepts can become the norm without all the rigors of normal scrutiny, our attention is focused on identifying Charcot neuroarthropathy (CN) at a stage before radiological bone destruction occurs. The rationale is that early recognition can prevent a destructive chain of events and thus potentially reduce the burden to patients and health care providers. In this article, we describe the evolution of stage 0 CN, and the use of modern imaging in characterizing the abnormalities recognized by these modalities and how they aid our understanding and supplement our knowledge. We review the potential of these imaging modalities, assessing how far we have come in characterizing stage 0 and if we have robust criteria for the identification of stage 0 in the natural history of CN.
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http://dx.doi.org/10.1177/15347346211011844DOI Listing
May 2021

A multicentre, randomised controlled clinical trial evaluating the effects of a novel autologous, heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Interim analysis.

Int Wound J 2021 May 4. Epub 2021 May 4.

Department of Medical Education, The Professional Education and Research Institute (PERI), Roanoke, Virginia, USA.

We desired to carefully evaluate a novel autologous heterogeneous skin construct in a prospective randomised clinical trial comparing this to a standard-of-care treatment in diabetic foot ulcers (DFUs). This study reports the interim analysis after the first half of the subjects have been analysed. Fifty patients (25 per group) with Wagner 1 ulcers were enrolled at 13 wound centres in the United States. Twenty-three subjects underwent the autologous heterogeneous skin construct harvest and application procedure once; two subjects required two applications due to loss of the first application. The primary endpoint was the proportion of wounds closed at 12 weeks. There were significantly more wounds closed in the treatment group (18/25; 72%) vs controls (8/25; 32%) at 12 weeks. The treatment group achieved significantly greater percent area reduction compared to the control group at every prespecified timepoint of 4, 6, 8, and 12 weeks. Thirty-eight adverse events occurred in 11 subjects (44%) in the treatment group vs 48 in 14 controls (56%), 6 of which required study removal. In the treatment group, there were no serious adverse events related to the index ulcer. Two adverse events (index ulcer cellulitis and bleeding) were possibly related to the autologous heterogeneous skin construct. Data from this planned interim analysis support that application of autologous heterogeneous skin construct may be potentially effective therapy for DFUs and provide supportive data to complete the planned study.
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http://dx.doi.org/10.1111/iwj.13598DOI Listing
May 2021

The Degree of Blood Supply and Infection Control Needed to Treat Diabetic Chronic Limb-Threatening Ischemia with Forefoot Osteomyelitis.

J Am Podiatr Med Assoc 2021 Mar;111(2)

Background: Diabetic foot ulcers combined with ischemia and infection can be difficult to treat. Few studies have quantified the level of blood supply and infection control required to treat such complex diabetic foot ulcers. We aimed to propose an index for ischemia and infection control in diabetic chronic limb-threatening ischemia (CLTI) with forefoot osteomyelitis.

Methods: We retrospectively evaluated 30 patients with diabetic CLTI combined with forefoot osteomyelitis who were treated surgically from January 2009 to December 2016. After 44 surgeries, we compared patient background (age, sex, hemodialysis), infection status (preoperative and 1- and 2-week postoperative C-reactive protein [CRP] levels), surgical bone margin (with or without osteomyelitis), vascular supply (skin perfusion pressure), ulcer size (wound grade 0-3 using the Society for Vascular Surgery Wound, Ischemia, and foot Infection classification), and time to wound healing between patients with healing ulcers and those with nonhealing ulcers.

Results: Preoperative CRP levels and the ratio of ulcers classified as wound grade 3 were significantly lower and skin perfusion pressure was significantly higher in the healing group than in the nonhealing group (P < .05). No other significant differences were found between groups.

Conclusions: This study demonstrates that debridement should be performed first to control infection if the preoperative CRP level is greater than 40 mg/L. Skin perfusion pressure of 55 mm Hg is strongly associated with successful treatment. We believe that this research could improve the likelihood of salvaging limbs in patients with diabetes with CLTI.
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http://dx.doi.org/10.7547/18-185DOI Listing
March 2021

Dosing Activity and Returning to Pre-Ulcer Function in Diabetic Foot Remission: Patient Recommendations and Guidance from the Limb Preservation Consortium at USC and The National Rehabilitation Center at Rancho Los Amigos.

J Am Podiatr Med Assoc 2021 Mar 29. Epub 2021 Mar 29.

Diabetes-related foot ulcers are a leading cause of global morbidity, mortality and healthcare costs. People with a history of foot ulcers have a diminished quality of life attributed to limited walking and mobility, decreased moderate intensity exercise when compared to people with diabetes without ulcers. One of the largest concerns is ulceration recurrence. Approximately 40% of patients with ulcerations will have a recurrent ulcer in the year following healing and the majority occurs in the first three months following wound healing. Hence this period after ulceration is called "remission" due to this risk for re-ulceration. Promoting and fostering mobility is an integral part of everyday life and is important for maintaining good physical health and health related quality of life for all people living with diabetes. In this short perspective, we provide recommendations on how to safely increase walking activity and facilitate appropriate offloading and monitoring in people with a recently healed foot ulcer, foot reconstruction or partial foot amputation. Interventions include monitored activity training, dosed out in steadily increasing increments and coupled with daily skin temperature monitoring which can identify dangerous "hot spots" prone to recurrence. By understanding areas at risk, it empowers patients to maximize ulcer-free days and to enable an improved quality of life. There is a current absence of high-quality evidence and standardized clinical algorithms for the post-ulcerative period. This perspective outlines this institution's unified strategy to treat patients in the remission period after ulceration. This approach utilizes the available evidence, identifies patient preferences, and relies on good clinical judgement for the best long-term outcomes for this patient population. Hence this position statement aims to provide clinicians with appropriate patient recommendations based on best available evidence and expert opinion to educate their patient to ensure a safe transition to footwear and return to activity.
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http://dx.doi.org/10.7547/20-166DOI Listing
March 2021

Steal syndrome from a superficial circumflex iliac perforator artery flap in a patient with a hypoplastic posterior tibial artery and severe diabetic peripheral artery disease.

J Surg Case Rep 2021 Mar 22;2021(3):rjab067. Epub 2021 Mar 22.

Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

The use of free flaps in lower extremity reconstructive surgery has seen growing adoption for treating tissue loss in patients with diabetes mellitus and peripheral artery disease as a means for limb preservation. The superficial circumflex iliac perforator artery (SCIP) flap is one of the most commonly utilized flaps in foot reconstruction and has demonstrated benefits over amputation. Patients with impaired vascular and neurologic function are predisposed to complications following lower extremity reconstructive surgery, particularly ischemia in the angiosomes of the arteries used for flap anastomosis. We present the case of a patient who underwent successful SCIP flap reconstruction of the calcaneus but developed gangrene in the forefoot region supplied by a hypoplastic posterior tibial artery in subsequent months. The changes in tissue oxygenation and hemoglobin distribution of the foot are shown using spatial frequency domain imaging throughout the flap healing process and eventual tissue necrosis.
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http://dx.doi.org/10.1093/jscr/rjab067DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7984850PMC
March 2021

Wound Bed Preparation 2021.

Adv Skin Wound Care 2021 Apr;34(4):183-195

General Purpose: To present the 2021 update of the Wound Bed Preparation paradigm.

Target Audience: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care.

Learning Objectives/outcomes: After participating in this educational activity, the participant will: 1. Apply wound assessment strategies. 2. Identify patient concerns about wound care. 3. Select management options for healable, nonhealable, and maintenance wounds.
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http://dx.doi.org/10.1097/01.ASW.0000733724.87630.d6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7982138PMC
April 2021

The Significance of the Global Vascular Guidelines for Podiatrists: Answers to Key Questions in the Diagnosis and Management of the Threatened Limb.

J Am Podiatr Med Assoc 2021 Mar 17. Epub 2021 Mar 17.

The publication of the Global Vascular Guidelines in 2019 provide evidence-based, best practice recommendations on the diagnosis and treatment of chronic limb-threatening ischemia (CLTI). Certainly, the multidisciplinary team, and more specifically one with collaborating podiatrists and vascular specialists, has been shown to be highly effective at improving the outcomes of limbs at risk for amputation. This article uses the Guidelines to answer key questions for podiatrists who are caring for the patient with CLTI.
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http://dx.doi.org/10.7547/20-217DOI Listing
March 2021

Nationwide prevalence and clinical characteristics of inpatient diabetic foot complications: A Peruvian multicenter study.

Prim Care Diabetes 2021 06 1;15(3):480-487. Epub 2021 Mar 1.

Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, Keck School of Medicine of University of Southern California, Los Angeles, California, USA. Electronic address:

Objective: To evaluate the burden of diabetic foot complications amongst inpatients in Peru.

Materials And Methods: Cross-sectional multicenter study, performed in public hospitals, in one-day enrollment between October and December 2018.

Results: We included 8346 patients from 39 national hospitals. Diabetic foot (DF) inpatient point prevalence was 2.8% (CI 95% 2.4-3.1), and DF point prevalence among Diabetes Mellitus (DM) inpatients was 18.9% (CI 95% 16.7-21.1). DF prevalence was higher in jungle and coastal hospitals than highlands ones, and there was no difference according to its care complexity level. Of the 234 patients with DF, 73% were males, age average was 62 ± 12 years, with DM mean time duration of 15 ± 9.9 years. Regarding to DF etiology, 91% and 68% had some degree of peripheral neuropathy and peripheral artery disease, respectively. According to the Infectious Diseases Society of America criteria, 61% presented moderate to severe infections, and 40% had bone involvement. Debridement within 48 h was performed in 36% of sepsis cases.

Conclusion: Peru has a substantial burden of DF disease, with a greater share of that burden falling on less equipped hospitals in the country's jungle and coastal regions. Interdisciplinary teams and pathways may improve the time of surgical debridement in the highest risk patients.
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http://dx.doi.org/10.1016/j.pcd.2021.02.009DOI Listing
June 2021

The Feasibility and Effectiveness of Wearable Sensor Technology in the Management of Elderly Diabetics with Foot Ulcer Remission: A Proof-Of-Concept Pilot Study with Six Cases.

Gerontology 2021 3;67(4):493-502. Epub 2021 Mar 3.

Bioengineering College and Department of Endocrinology, Chongqing University Central Hospital, Key Laboratory for Biorheological Science and Technology of Ministry of Education, Chongqing University, Chongqing, China,

Aims: Using specials wearable sensors, we explored changes in gait and balance parameters, over time, in elderly patients at high risk of diabetic foot, wearing different types of footwear. This assessed the relationship between gait and balance changes in elderly diabetic patients and the development of foot ulcers, in a bid to uncover potential benefits of wearable devices in the prognosis and management of the aforementioned complication.

Methods: A wearable sensor-based monitoring system was used in middle-elderly patients with diabetes who recently recovered from neuropathic plantar foot ulcers. A total of 6 patients (age range: 55-80 years) were divided into 2 groups: the therapeutic footwear group (n = 3) and the regular footwear (n = 3) group. All subjects were assessed for gait and balance throughout the study period. Walking ability and gait pattern were assessed by allowing participants to walk normally for 1 min at habitual speed. The balance assessment program incorporated the "feet together" standing test and the instrumented modified Clinical Test of Sensory Integration and Balance. Biomechanical information was monitored at least 3 times.

Results: We found significant differences in stride length (p < 0.0001), stride velocity (p < 0.0001), and double support (p < 0.0001) between the offloading footwear group (OG) and the regular footwear group on a group × time interaction. The balance test embracing eyes-open condition revealed a significant difference in Hip Sway (p = 0.004), COM Range ML (p = 0.008), and COM Position (p = 0.004) between the 2 groups. Longitudinally, the offloading group exhibited slight improvement in the performance of gait parameters over time. The stride length (odds ratio 3.54, 95% CI 1.34-9.34, p = 0.018) and velocity (odds ratio 3.13, 95% CI 1.19-8.19, p = 0.033) of OG patients increased, converse to the double-support period (odds ratio 6.20, 95% CI 1.97-19.55, p = 0.002), which decreased.

Conclusions: Special wearable devices can accurately monitor gait and balance parameters in patients in real time. The finding reveals the feasibility and effectiveness of advanced wearable sensors in the prevention and management of diabetic foot ulcer and provides a solid background for future research. In addition, the development of foot ulcers in elderly diabetic patients may be associated with changes in gait parameters and the nature of footwear. Even so, larger follow-up studies are needed to validate our findings.
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http://dx.doi.org/10.1159/000513729DOI Listing
November 2021
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