Alexander Reyzelman - Academia.edu (original) (raw)

Papers by Alexander Reyzelman

Research paper thumbnail of Open revascularization approach is associated with healing and ambulation after transmetatarsal amputation in patients with chronic limb threatening ischemia

Journal of Vascular Surgery

Research paper thumbnail of Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers: a prospective randomised controlled trial

Journal of Wound Care

Aim: The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine... more Aim: The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine acellular dermal matrix (FBADM) plus standard of care (SOC) for treating hard-to-heal diabetic foot ulcers (DFUs). Method: A prospective, multi-centre, randomised controlled trial was carried out. The study included a 2-week run-in period, a 12-week treatment phase and a 4-week follow-up phase. The primary endpoint was complete wound closure at 12 weeks. Results: Twenty-one US sites enrolled and randomised 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients, with 103 in the FBADM group and 104 in the SOC group. Of these participants, 161 completed the study per protocol (mPP population), with 79 receiving FBADM, and 82 without. At the first analysis point, patients treated with FBADM were found to be significantly more likely to achieve complete wound closure compared ...

Research paper thumbnail of A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer

Wounds : a compendium of clinical research and practice, 2016

UNLABELLED Delayed closure of foot ulcers is a primary factor leading to lower extremity amputati... more UNLABELLED Delayed closure of foot ulcers is a primary factor leading to lower extremity amputation in patients with diabetes, creating great demand for products or therapies to accelerate the rate of wound closure in this population. This study (ClinicalTrials.gov Identifier: NCT02209051) was designed to evaluate dehydrated amniotic membrane allograft (DAMA) (AMNIOEXCEL, Derma Sciences Inc, Princeton, NJ) plus standard of care (SOC) compared to SOC alone for the closure of chronic diabetic foot ulcers (DFUs). MATERIALS AND METHODS This prospective, open-label, randomized, parallel group trial was implemented at 8 clinical sites in the United States. Eligibility criteria included adults with type 1 or type 2 diabetes mellitus who have 1 or more ulcers with a Wagner classification of grade 1 or superficial 2 measuring between 1 cm2 and 25 cm2 in area, presenting for more than 1 month with no signs of infection/osteomyelitis; ABI > 0.7; HbA1c Less than 12%; and serum creatinine les...

Research paper thumbnail of Evaluation of Real-World Smart Sock-Based Temperature Monitoring Data as a Physiological Indicator of Early Diabetic Foot Injury: Case-Control Study (Preprint)

BACKGROUND Diabetic foot ulcers represent major health care complications both in terms of cost a... more BACKGROUND Diabetic foot ulcers represent major health care complications both in terms of cost and impact to quality of life for patients with diabetic peripheral neuropathy. Temperature monitoring has been shown in previous studies to provide a useful signal of inflammation that may indicate the early presence of a foot injury. OBJECTIVE In this study we evaluated the temperature data for patients that presented with a diabetic foot injury while utilizing a sock-based remote temperature monitoring device. METHODS The study abstracted data from patients enrolled in a remote temperature monitoring program in year 2020-2021 using a smart sock (Siren Care, San Francisco, California, USA). In the study cohort, a total of 5 participants with a diabetes-related lower extremity injury during study period were identified. In the second comparison cohort, a total of 26 patients met the criteria for monitoring by the same methods that did not present with a diabetes-related podiatric injury ...

Research paper thumbnail of Evidence of Intensive Autolytic Debridement With a Self-Adaptive Wound Dressing

Wounds : a compendium of clinical research and practice, 2015

BACKGROUND Chronic venous leg ulcers (VLUs) can be challenging to manage and heal. Despite the ob... more BACKGROUND Chronic venous leg ulcers (VLUs) can be challenging to manage and heal. Despite the observed efficacy of surgical debridement, many patients with VLUs refuse the procedure due to the associated pain. Autolytic debridement induces no pain, but is slow or disrupted in chronic VLUs. Elucidation of the wound dressing functions that are sufficient to support autolytic debridement is needed. MATERIALS AND METHODS The authors report 2 challenging cases with large, nonresponsive VLUs. A 52-year-old female patient, Case 1, presented with a VLU of 91.4 cm(2) (10.5 cm x 8.7 cm); and a 58-year-old female patient, Case 2, presented with bilateral VLUs, the larger of which was 50 cm(2) (10 cm x 5 cm). Both VLU cases were covered with yellow slough, and case 1 had a small area of black necrotic tissue. The patients had received standard care for more than 16 months, but their VLUs were worsening. A self-adaptive wound dressing (SAWD) with a compression wrap was applied 2 to 3 times a we...

Research paper thumbnail of Impact of the coronavirus disease 2019 pandemic on an academic vascular practice and a multidisciplinary limb preservation program

Journal of Vascular Surgery

Research paper thumbnail of Remote Patient Monitoring Utilization of a Smart Sock Among Patients with Peripheral Neuropathy: Real-World Registry Findings (Preprint)

BACKGROUND Remote patient monitoring (RPM) devices are increasingly utilized in caring for patien... more BACKGROUND Remote patient monitoring (RPM) devices are increasingly utilized in caring for patients to reduce risks of complications. Temperature monitoring specifically has been shown in previous studies to provide a useful signal of inflammation that may help prevent foot ulcers. OBJECTIVE In this study we evaluated the utilization data for patients prescribed smart socks as remote temperature monitoring devices. METHODS The study evaluated data from a patient registry from January to July 2021. The utilization data beginning the first full month of being on the smart socks was evaluated along with retention over time, average time worn, and number of days worn per month and per week. RESULTS 162 patients wore the smart socks RPM device between 22-25 days a month on average. Retention was 93% at the end of the 7-month period with a total of 12 patients that were lost to follow-up during the period. Average days worn per week was 5.8. The percent of patients with utilization greate...

Research paper thumbnail of Pedal arterial calcification score is associated with risk of major amputation in chronic limb-threatening ischemia

Journal of Vascular Surgery

Research paper thumbnail of A prospective, randomized, controlled, crossover study comparing three multilayered foam dressings for the management of chronic wounds

Journal of Comparative Effectiveness Research

Aim: Compare foam dressings – Mepilex Border Flex (MxBF), Allevyn Life (AL) and Optifoam Gentle E... more Aim: Compare foam dressings – Mepilex Border Flex (MxBF), Allevyn Life (AL) and Optifoam Gentle EX (OGEX) – in treatment of chronic wounds. Materials & methods: Prospective, randomized, controlled trial (crossover design). Subjects received one dressing for 2 weeks, then comparator dressing for following 2 weeks. Wound/periwound characteristics evaluated weekly at dressing change. Primary end point: dressing durability (incidence of exudate strikethrough). Results: Higher incidence of intact dressings (no strikethrough) at Day 7 (Week 1) with MxBF (6/17; 35.3%) compared with AL (1/18; 5.6%), and with MxBF (7/16; 43.8%) compared with OGEX (2/16; 12.5%; p

Research paper thumbnail of 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

International Wound Journal

We desired to carefully evaluate a novel autologous heterogeneous skin construct in a prospective... more 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.

Research paper thumbnail of Abstract 13208: Pedal Arterial Calcification Score Correlates With Risk of Death and Major Adverse Cardiovascular Event in Patients With Chronic Limb Threatening Ischemia

Circulation

Introduction: Peripheral arterial disease is associated with cardiovascular morbidity and mortali... more Introduction: Peripheral arterial disease is associated with cardiovascular morbidity and mortality, and the burden of PAD can be used to reclassify risk within CVD models. We describe a novel, practical score for quantifying peripheral arterial calcification based on plain x-ray films of the foot (MAC). We hypothesize that high MAC score is associated with risk of death and major adverse cardiovascular events (MACE; defined as MI, coronary intervention, CVA, TIA) in patients with chronic limb-threatening ischemia (CLTI). Methods: This is a single-institution retrospective study of 275 patients who underwent infrainguinal revascularization for CLTI between 1/2011 and 7/2019. MAC scores were calculated by a single blinded reviewer using two-view plain foot radiographs. Each patient was assigned a score of 0-5, with 1 point each for calcifications > 2 cm in the dorsalis pedis, plantar and metatarsal arteries, and > 1 cm in the hallux and non-hallux digital arteries. Results: The...

Research paper thumbnail of Pedal Arterial Calcification Score Correlates With Risk of Major Amputation in Chronic Limb-Threatening Ischemia

Journal of Vascular Surgery

Research paper thumbnail of Lower Extremity Revascularization With Transmetatarsal Amputation Improves Healing and Reduces Major Amputation

Journal of Vascular Surgery

Research paper thumbnail of A Comparative Diabetic Foot Wound Measurement Trial Using Wound Tracker Professional Versus Aranz Imaging System and Conventional Ruler Measurement

Clinics in Podiatric Medicine and Surgery

This is a prospective clinical trial comparing Wound Tracker Professional iOS compatible device w... more This is a prospective clinical trial comparing Wound Tracker Professional iOS compatible device with Acetate tracing and Aranz medical wound measuring systems. The study compares 3 different wound measurement systems in 20 patients. Wound Tracker Professional device demonstrated statistically significant difference when compared with the acetate tracing; however, there was no statistically significant difference when compared with the Aranz system. Wound Tracker Professional iOS compatible system is an easily accessible and affordable wound measuring system that can easily be implemented by the clinician in a wound care setting.

Research paper thumbnail of Increased Re-intervention Following Infrainguinal Revascularization For Chronic Limb-threatening Ischemia In Women

Annals of Vascular Surgery

Research paper thumbnail of Wound Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells

Advances in Wound Care

Objective: To evaluate the clinical outcomes of lyopreserved placental membrane containing viable... more Objective: To evaluate the clinical outcomes of lyopreserved placental membrane containing viable cells (vLPM) in the treatment of nonhealing wounds of various etiologies, and to compare them to those previously reported for cryopreserved placental membrane containing viable cells (vCPM). Approach: Patients with nonhealing wounds who qualified to receive advanced wound therapies were consecutively enrolled and treated weekly with vLPM plus standard of care (SOC) at five centers. Data were de-identified and retrospectively analyzed. Outcomes included closure, time to closure, number of vLPM applications, and adverse events (AEs). Results: Seventy-eight patients with 98 wounds (41 diabetic foot ulcers [DFUs], 19 venous leg ulcers [VLUs], 10 surgical, and 28 others) with an average size of 13.3 cm 2 and 8.7 months duration were treated. Fifty-eight of the 98 wounds (59.2%) achieved complete closure with median time to closure of 63 days and 6 vLPM applications. The closure by wound etiology was 63% for DFUs, 47% for VLUs, 70% for surgical wounds, and 57% for other types of wounds. Similar closure rates have been previously demonstrated for vCPM. Wound duration was the main predictor of closure: 65.8% versus 30.0% (p = 0.004) closure was achieved for wounds of £12 and >12 months duration, respectively. There were no AEs related to vLPM application. Innovation: This is the first multicenter case series evaluating the clinical outcomes of vLPM in a real-world setting. Conclusion: These results support clinical equivalency between the two placental membrane formulations with the added convenience of room-temperature storage for vLPM, allowing it to be used in any wound-care setting.

Research paper thumbnail of Human placental membrane as a wound cover for chronic diabetic foot ulcers: a prospective, postmarket, CLOSURE study

Journal of Wound Care

OBJECTIVE To evaluate the safety and efficacy of a chorioamniotic allograft, used as a wound cove... more OBJECTIVE To evaluate the safety and efficacy of a chorioamniotic allograft, used as a wound cover for chronic foot ulcers, in patients with diabetes. METHODS A multicentre, prospective, postmarket study where eligible patients received up to 11 weekly wound cover applications. Computerised planimetry was used to calculate the diabetic foot ulcer (DFU) area each week. The primary endpoint of the study was wound closure assessment. Secondary endpoints included DFU recurrence and morbidity. RESULTS A total of 63 patients with 64 ulcers were enrolled, after successful completion of a two-week run-in period. Patients were predominantly male and had risk factors for delayed healing. Mean baseline DFU area was 3.8cm2 (standard deviation (SD): 4.8). After 12 weeks, a total of 19 (40%) DFUs had closed. Results varied by size category, 'small' (≤2.0cm2), 'medium' (>2.0-4.0 cm2), and 'large' (>4.0-25.0 cm2), with higher percentage closure in the 'small' DFU group, compared with the 'medium' and 'large' DFUs (57%, 33%, and 10%, respectively). Of those DFUs that closed, the average closure time was 6.5 weeks. There were no unanticipated adverse events. CONCLUSION Known risk factors for healing, including DFU size, location and duration, affected the outcomes. However, the results are in line with the literature and support the use of the chorioamniotic allograft in chronic and complex cases.

Research paper thumbnail of Continuous Temperature Monitoring Socks for Home Use in Patients with Diabetes (Preprint)

BACKGROUND Over 30 million people in the United States (over 9%) have been diagnosed with diabete... more BACKGROUND Over 30 million people in the United States (over 9%) have been diagnosed with diabetes. About 25% of people with diabetes will experience a foot ulcer (DFU) in their lifetime. Unresolved DFUs may lead to sepsis and are the leading case of lower limb amputations. DFU rates can be reduced by screening patients with diabetes to enable risk-based interventions. Skin temperature assessment has been shown to reduce the risk of foot ulceration. While several tools have been developed to measure plantar temperatures, they measure temperature once a day or are designed for clinic use only. In this report, wireless sensor-embedded socks designed for daily wear are introduced, which perform continuous temperature monitoring of the feet of persons with diabetes in the home environment. Combined with a mobile app, this wearable device informs the wearer about temperature increases in one foot relative to the other, to facilitate early detection of ulcers and timely intervention. OBJE...

Research paper thumbnail of A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics

International wound journal, Jan 22, 2018

A randomised, controlled multicentre clinical trial was conducted at 14 wound care centres in the... more A randomised, controlled multicentre clinical trial was conducted at 14 wound care centres in the United States to confirm the efficacy of dehydrated human amnion/chorion membrane allograft (dHACM) for the treatment of chronic lower extremity ulcers in persons with diabetes. Patients with a lower extremity ulcer of at least 4 weeks duration were entered into a 2-week study run-in phase and treated with alginate wound dressings and appropriate offloading. Those with less than or equal to 25% wound closure after run-in were randomly assigned to receive weekly dHACM application in addition to offloading or standard of care with alginate wound dressings, for 12 weeks. A total of 110 patients were included in the intent-to-treat (ITT) analysis, with n = 54 in the dHACM group and n = 56 in the no-dHACM group. Of the participants, 98 completed the study per protocol, with 47 receiving dHACM and 51 not receiving dHACM. The primary study outcome was percentage of study ulcers completely heal...

Research paper thumbnail of A Prospective, Randomized, Blinded, Controlled Trial Comparing Transdermal Continuous Oxygen Delivery to Moist Wound Therapy for the Treatment of Diabetic Foot Ulcers

Ostomy/wound management, 2017

Worldwide, diabetic foot ulcers (DFUs) continue to exact a major burden on patients and health ca... more Worldwide, diabetic foot ulcers (DFUs) continue to exact a major burden on patients and health care providers. Although hyperbaric oxygen therapy is well-known as an adjunct option, less is known about the efficacy of transdermal continuous oxygen therapy (TCOT). A prospective, randomized, blinded, multicenter, parallel study was conducted from October 2009 to November 2012 to evaluate healing time and the proportion of DFUs healed after 12 weeks of moist wound therapy (MWT) with or without TCOT. Study participants (persons with type 1 or type 2 diabetes and a nonhealing [>1-month but <1-year duration], 1 cm² to 10 cm² in area, infection-free DFU) were randomized to TCOT or a sham device (control) in addition to receiving MWT. TCOT treatment consisted of continuous administration of 98+% oxygen to the wound site using a 15-day device with dressings changed every 3 to 7 days per care plan or more often when clinically required. Potential participants completed demographic and c...

Research paper thumbnail of Open revascularization approach is associated with healing and ambulation after transmetatarsal amputation in patients with chronic limb threatening ischemia

Journal of Vascular Surgery

Research paper thumbnail of Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers: a prospective randomised controlled trial

Journal of Wound Care

Aim: The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine... more Aim: The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine acellular dermal matrix (FBADM) plus standard of care (SOC) for treating hard-to-heal diabetic foot ulcers (DFUs). Method: A prospective, multi-centre, randomised controlled trial was carried out. The study included a 2-week run-in period, a 12-week treatment phase and a 4-week follow-up phase. The primary endpoint was complete wound closure at 12 weeks. Results: Twenty-one US sites enrolled and randomised 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients, with 103 in the FBADM group and 104 in the SOC group. Of these participants, 161 completed the study per protocol (mPP population), with 79 receiving FBADM, and 82 without. At the first analysis point, patients treated with FBADM were found to be significantly more likely to achieve complete wound closure compared ...

Research paper thumbnail of A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer

Wounds : a compendium of clinical research and practice, 2016

UNLABELLED Delayed closure of foot ulcers is a primary factor leading to lower extremity amputati... more UNLABELLED Delayed closure of foot ulcers is a primary factor leading to lower extremity amputation in patients with diabetes, creating great demand for products or therapies to accelerate the rate of wound closure in this population. This study (ClinicalTrials.gov Identifier: NCT02209051) was designed to evaluate dehydrated amniotic membrane allograft (DAMA) (AMNIOEXCEL, Derma Sciences Inc, Princeton, NJ) plus standard of care (SOC) compared to SOC alone for the closure of chronic diabetic foot ulcers (DFUs). MATERIALS AND METHODS This prospective, open-label, randomized, parallel group trial was implemented at 8 clinical sites in the United States. Eligibility criteria included adults with type 1 or type 2 diabetes mellitus who have 1 or more ulcers with a Wagner classification of grade 1 or superficial 2 measuring between 1 cm2 and 25 cm2 in area, presenting for more than 1 month with no signs of infection/osteomyelitis; ABI > 0.7; HbA1c Less than 12%; and serum creatinine les...

Research paper thumbnail of Evaluation of Real-World Smart Sock-Based Temperature Monitoring Data as a Physiological Indicator of Early Diabetic Foot Injury: Case-Control Study (Preprint)

BACKGROUND Diabetic foot ulcers represent major health care complications both in terms of cost a... more BACKGROUND Diabetic foot ulcers represent major health care complications both in terms of cost and impact to quality of life for patients with diabetic peripheral neuropathy. Temperature monitoring has been shown in previous studies to provide a useful signal of inflammation that may indicate the early presence of a foot injury. OBJECTIVE In this study we evaluated the temperature data for patients that presented with a diabetic foot injury while utilizing a sock-based remote temperature monitoring device. METHODS The study abstracted data from patients enrolled in a remote temperature monitoring program in year 2020-2021 using a smart sock (Siren Care, San Francisco, California, USA). In the study cohort, a total of 5 participants with a diabetes-related lower extremity injury during study period were identified. In the second comparison cohort, a total of 26 patients met the criteria for monitoring by the same methods that did not present with a diabetes-related podiatric injury ...

Research paper thumbnail of Evidence of Intensive Autolytic Debridement With a Self-Adaptive Wound Dressing

Wounds : a compendium of clinical research and practice, 2015

BACKGROUND Chronic venous leg ulcers (VLUs) can be challenging to manage and heal. Despite the ob... more BACKGROUND Chronic venous leg ulcers (VLUs) can be challenging to manage and heal. Despite the observed efficacy of surgical debridement, many patients with VLUs refuse the procedure due to the associated pain. Autolytic debridement induces no pain, but is slow or disrupted in chronic VLUs. Elucidation of the wound dressing functions that are sufficient to support autolytic debridement is needed. MATERIALS AND METHODS The authors report 2 challenging cases with large, nonresponsive VLUs. A 52-year-old female patient, Case 1, presented with a VLU of 91.4 cm(2) (10.5 cm x 8.7 cm); and a 58-year-old female patient, Case 2, presented with bilateral VLUs, the larger of which was 50 cm(2) (10 cm x 5 cm). Both VLU cases were covered with yellow slough, and case 1 had a small area of black necrotic tissue. The patients had received standard care for more than 16 months, but their VLUs were worsening. A self-adaptive wound dressing (SAWD) with a compression wrap was applied 2 to 3 times a we...

Research paper thumbnail of Impact of the coronavirus disease 2019 pandemic on an academic vascular practice and a multidisciplinary limb preservation program

Journal of Vascular Surgery

Research paper thumbnail of Remote Patient Monitoring Utilization of a Smart Sock Among Patients with Peripheral Neuropathy: Real-World Registry Findings (Preprint)

BACKGROUND Remote patient monitoring (RPM) devices are increasingly utilized in caring for patien... more BACKGROUND Remote patient monitoring (RPM) devices are increasingly utilized in caring for patients to reduce risks of complications. Temperature monitoring specifically has been shown in previous studies to provide a useful signal of inflammation that may help prevent foot ulcers. OBJECTIVE In this study we evaluated the utilization data for patients prescribed smart socks as remote temperature monitoring devices. METHODS The study evaluated data from a patient registry from January to July 2021. The utilization data beginning the first full month of being on the smart socks was evaluated along with retention over time, average time worn, and number of days worn per month and per week. RESULTS 162 patients wore the smart socks RPM device between 22-25 days a month on average. Retention was 93% at the end of the 7-month period with a total of 12 patients that were lost to follow-up during the period. Average days worn per week was 5.8. The percent of patients with utilization greate...

Research paper thumbnail of Pedal arterial calcification score is associated with risk of major amputation in chronic limb-threatening ischemia

Journal of Vascular Surgery

Research paper thumbnail of A prospective, randomized, controlled, crossover study comparing three multilayered foam dressings for the management of chronic wounds

Journal of Comparative Effectiveness Research

Aim: Compare foam dressings – Mepilex Border Flex (MxBF), Allevyn Life (AL) and Optifoam Gentle E... more Aim: Compare foam dressings – Mepilex Border Flex (MxBF), Allevyn Life (AL) and Optifoam Gentle EX (OGEX) – in treatment of chronic wounds. Materials & methods: Prospective, randomized, controlled trial (crossover design). Subjects received one dressing for 2 weeks, then comparator dressing for following 2 weeks. Wound/periwound characteristics evaluated weekly at dressing change. Primary end point: dressing durability (incidence of exudate strikethrough). Results: Higher incidence of intact dressings (no strikethrough) at Day 7 (Week 1) with MxBF (6/17; 35.3%) compared with AL (1/18; 5.6%), and with MxBF (7/16; 43.8%) compared with OGEX (2/16; 12.5%; p

Research paper thumbnail of 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

International Wound Journal

We desired to carefully evaluate a novel autologous heterogeneous skin construct in a prospective... more 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.

Research paper thumbnail of Abstract 13208: Pedal Arterial Calcification Score Correlates With Risk of Death and Major Adverse Cardiovascular Event in Patients With Chronic Limb Threatening Ischemia

Circulation

Introduction: Peripheral arterial disease is associated with cardiovascular morbidity and mortali... more Introduction: Peripheral arterial disease is associated with cardiovascular morbidity and mortality, and the burden of PAD can be used to reclassify risk within CVD models. We describe a novel, practical score for quantifying peripheral arterial calcification based on plain x-ray films of the foot (MAC). We hypothesize that high MAC score is associated with risk of death and major adverse cardiovascular events (MACE; defined as MI, coronary intervention, CVA, TIA) in patients with chronic limb-threatening ischemia (CLTI). Methods: This is a single-institution retrospective study of 275 patients who underwent infrainguinal revascularization for CLTI between 1/2011 and 7/2019. MAC scores were calculated by a single blinded reviewer using two-view plain foot radiographs. Each patient was assigned a score of 0-5, with 1 point each for calcifications > 2 cm in the dorsalis pedis, plantar and metatarsal arteries, and > 1 cm in the hallux and non-hallux digital arteries. Results: The...

Research paper thumbnail of Pedal Arterial Calcification Score Correlates With Risk of Major Amputation in Chronic Limb-Threatening Ischemia

Journal of Vascular Surgery

Research paper thumbnail of Lower Extremity Revascularization With Transmetatarsal Amputation Improves Healing and Reduces Major Amputation

Journal of Vascular Surgery

Research paper thumbnail of A Comparative Diabetic Foot Wound Measurement Trial Using Wound Tracker Professional Versus Aranz Imaging System and Conventional Ruler Measurement

Clinics in Podiatric Medicine and Surgery

This is a prospective clinical trial comparing Wound Tracker Professional iOS compatible device w... more This is a prospective clinical trial comparing Wound Tracker Professional iOS compatible device with Acetate tracing and Aranz medical wound measuring systems. The study compares 3 different wound measurement systems in 20 patients. Wound Tracker Professional device demonstrated statistically significant difference when compared with the acetate tracing; however, there was no statistically significant difference when compared with the Aranz system. Wound Tracker Professional iOS compatible system is an easily accessible and affordable wound measuring system that can easily be implemented by the clinician in a wound care setting.

Research paper thumbnail of Increased Re-intervention Following Infrainguinal Revascularization For Chronic Limb-threatening Ischemia In Women

Annals of Vascular Surgery

Research paper thumbnail of Wound Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells

Advances in Wound Care

Objective: To evaluate the clinical outcomes of lyopreserved placental membrane containing viable... more Objective: To evaluate the clinical outcomes of lyopreserved placental membrane containing viable cells (vLPM) in the treatment of nonhealing wounds of various etiologies, and to compare them to those previously reported for cryopreserved placental membrane containing viable cells (vCPM). Approach: Patients with nonhealing wounds who qualified to receive advanced wound therapies were consecutively enrolled and treated weekly with vLPM plus standard of care (SOC) at five centers. Data were de-identified and retrospectively analyzed. Outcomes included closure, time to closure, number of vLPM applications, and adverse events (AEs). Results: Seventy-eight patients with 98 wounds (41 diabetic foot ulcers [DFUs], 19 venous leg ulcers [VLUs], 10 surgical, and 28 others) with an average size of 13.3 cm 2 and 8.7 months duration were treated. Fifty-eight of the 98 wounds (59.2%) achieved complete closure with median time to closure of 63 days and 6 vLPM applications. The closure by wound etiology was 63% for DFUs, 47% for VLUs, 70% for surgical wounds, and 57% for other types of wounds. Similar closure rates have been previously demonstrated for vCPM. Wound duration was the main predictor of closure: 65.8% versus 30.0% (p = 0.004) closure was achieved for wounds of £12 and >12 months duration, respectively. There were no AEs related to vLPM application. Innovation: This is the first multicenter case series evaluating the clinical outcomes of vLPM in a real-world setting. Conclusion: These results support clinical equivalency between the two placental membrane formulations with the added convenience of room-temperature storage for vLPM, allowing it to be used in any wound-care setting.

Research paper thumbnail of Human placental membrane as a wound cover for chronic diabetic foot ulcers: a prospective, postmarket, CLOSURE study

Journal of Wound Care

OBJECTIVE To evaluate the safety and efficacy of a chorioamniotic allograft, used as a wound cove... more OBJECTIVE To evaluate the safety and efficacy of a chorioamniotic allograft, used as a wound cover for chronic foot ulcers, in patients with diabetes. METHODS A multicentre, prospective, postmarket study where eligible patients received up to 11 weekly wound cover applications. Computerised planimetry was used to calculate the diabetic foot ulcer (DFU) area each week. The primary endpoint of the study was wound closure assessment. Secondary endpoints included DFU recurrence and morbidity. RESULTS A total of 63 patients with 64 ulcers were enrolled, after successful completion of a two-week run-in period. Patients were predominantly male and had risk factors for delayed healing. Mean baseline DFU area was 3.8cm2 (standard deviation (SD): 4.8). After 12 weeks, a total of 19 (40%) DFUs had closed. Results varied by size category, 'small' (≤2.0cm2), 'medium' (>2.0-4.0 cm2), and 'large' (>4.0-25.0 cm2), with higher percentage closure in the 'small' DFU group, compared with the 'medium' and 'large' DFUs (57%, 33%, and 10%, respectively). Of those DFUs that closed, the average closure time was 6.5 weeks. There were no unanticipated adverse events. CONCLUSION Known risk factors for healing, including DFU size, location and duration, affected the outcomes. However, the results are in line with the literature and support the use of the chorioamniotic allograft in chronic and complex cases.

Research paper thumbnail of Continuous Temperature Monitoring Socks for Home Use in Patients with Diabetes (Preprint)

BACKGROUND Over 30 million people in the United States (over 9%) have been diagnosed with diabete... more BACKGROUND Over 30 million people in the United States (over 9%) have been diagnosed with diabetes. About 25% of people with diabetes will experience a foot ulcer (DFU) in their lifetime. Unresolved DFUs may lead to sepsis and are the leading case of lower limb amputations. DFU rates can be reduced by screening patients with diabetes to enable risk-based interventions. Skin temperature assessment has been shown to reduce the risk of foot ulceration. While several tools have been developed to measure plantar temperatures, they measure temperature once a day or are designed for clinic use only. In this report, wireless sensor-embedded socks designed for daily wear are introduced, which perform continuous temperature monitoring of the feet of persons with diabetes in the home environment. Combined with a mobile app, this wearable device informs the wearer about temperature increases in one foot relative to the other, to facilitate early detection of ulcers and timely intervention. OBJE...

Research paper thumbnail of A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics

International wound journal, Jan 22, 2018

A randomised, controlled multicentre clinical trial was conducted at 14 wound care centres in the... more A randomised, controlled multicentre clinical trial was conducted at 14 wound care centres in the United States to confirm the efficacy of dehydrated human amnion/chorion membrane allograft (dHACM) for the treatment of chronic lower extremity ulcers in persons with diabetes. Patients with a lower extremity ulcer of at least 4 weeks duration were entered into a 2-week study run-in phase and treated with alginate wound dressings and appropriate offloading. Those with less than or equal to 25% wound closure after run-in were randomly assigned to receive weekly dHACM application in addition to offloading or standard of care with alginate wound dressings, for 12 weeks. A total of 110 patients were included in the intent-to-treat (ITT) analysis, with n = 54 in the dHACM group and n = 56 in the no-dHACM group. Of the participants, 98 completed the study per protocol, with 47 receiving dHACM and 51 not receiving dHACM. The primary study outcome was percentage of study ulcers completely heal...

Research paper thumbnail of A Prospective, Randomized, Blinded, Controlled Trial Comparing Transdermal Continuous Oxygen Delivery to Moist Wound Therapy for the Treatment of Diabetic Foot Ulcers

Ostomy/wound management, 2017

Worldwide, diabetic foot ulcers (DFUs) continue to exact a major burden on patients and health ca... more Worldwide, diabetic foot ulcers (DFUs) continue to exact a major burden on patients and health care providers. Although hyperbaric oxygen therapy is well-known as an adjunct option, less is known about the efficacy of transdermal continuous oxygen therapy (TCOT). A prospective, randomized, blinded, multicenter, parallel study was conducted from October 2009 to November 2012 to evaluate healing time and the proportion of DFUs healed after 12 weeks of moist wound therapy (MWT) with or without TCOT. Study participants (persons with type 1 or type 2 diabetes and a nonhealing [>1-month but <1-year duration], 1 cm² to 10 cm² in area, infection-free DFU) were randomized to TCOT or a sham device (control) in addition to receiving MWT. TCOT treatment consisted of continuous administration of 98+% oxygen to the wound site using a 15-day device with dressings changed every 3 to 7 days per care plan or more often when clinically required. Potential participants completed demographic and c...