Effectiveness of a Continuous Remote Temperature Monitoring Program to Reduce Foot Ulcers and Amputations: Multicenter Postmarket Registry Study.

Background: Neuropathic foot ulcers are the leading cause of nontraumatic foot amputations, particularly among patients with diabetes. Traditional methods of monitoring and managing these patients are periodic in-person clinic visits, which are passive and may be insufficient for preventing neuropathic foot ulcers and amputations. Continuous remote temperature monitoring has the potential to capture the critical period before the foot ulcers develop and to improve outcomes by providing real-time data and early interventions.

The influence of adequate debridement and placental-derived allografts on diabetic foot ulcers.

Objective: To determine the role of debridement when patients are using placental-derived allografts (PDAs), data from two prospective, multicentre, randomised controlled trials (RCTs) were evaluated for the quality or adequacy of debridement on diabetic foot ulcers (DFUs) treated with PDAs. Results were compared with real-world findings via a retrospective analysis of 2015-2019 Medicare claims for DFUs.

Method: Debridement adequacy in the prospective RCTs was adjudicated by three blinded wound care specialists.

Pedal arterial calcification score is associated with hemodynamic change and major amputation after infrainguinal revascularization for chronic limb-threatening ischemia.

Objective: Pedal medial arterial calcification (pMAC) is associated with major amputation in patients with chronic limb-threatening ischemia (CLTI). We hypothesize that this association would be related to unresolved distal ischemia. We investigated relationships across pMAC score, hemodynamic change, and major amputation after infrainguinal revascularization for CLTI.

An Evaluation of Real-world Smart Sock-Based Temperature Monitoring Data as a Physiological Indicator of Early Diabetic Foot Injury: Case-Control Study.

Background: Lower extremity complications of diabetes 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 using a sock-based remote temperature monitoring device.

Utilization of a Smart Sock for the Remote Monitoring of Patients With Peripheral Neuropathy: Cross-sectional Study of a Real-world Registry.

Background: Remote patient monitoring (RPM) devices are increasingly being used 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 cross-sectional study, we evaluated utilization data for patients who were prescribed smart socks as remote temperature monitoring devices.

Multi-centre prospective randomised controlled clinical trial to evaluate a bioactive split thickness skin allograft vs standard of care in the treatment of diabetic foot ulcers.

Diabetic foot ulcers (DFUs) pose a significant risk for infection and limb loss. Advanced wound therapies including human skin allografts have shown promise in resolving these challenging wounds. The primary objective of this randomised, prospective study was to compare the response of 100 subjects with non-healing DFUs of which 50 were treated with a cryopreserved bioactive split thickness skin allograft (BSA) (TheraSkin; Misonix,Inc.

Pedal arterial calcification score is associated with the risk of major amputation in chronic limb-threatening ischemia.

Objective: The medial arterial calcification (MAC) score is a simple metric that describes the burden of inframalleolar calcification using a plain foot radiograph. We hypothesized that a higher MAC score would be independently associated with the risk of major amputation in patients with chronic limb-threatening ischemia (CLTI).

Methods: We performed a single-institution, retrospective study of 250 patients who had undergone infrainguinal revascularization for CLTI from January 2011 to July 2019 and had foot radiographs available for MAC score calculation.

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

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.

Increased Reintervention After Infrainguinal Revascularization for Chronic Limb-Threatening Ischemia in Women.

Background: The objective of this study was to determine if there are gender-based differences in major adverse limb events after revascularization for chronic limb-threatening ischemia (CLTI) and to identify potential associated factors.

Methods: This was a single-center retrospective analysis of 151 patients who underwent infrainguinal revascularization for CLTI between April 2013 and December 2015. Only the first revascularized limb was included in patients with bilateral CLTI.

A Comparative Diabetic Foot Wound Measurement Trial Using Wound Tracker Professional Versus Aranz Imaging System and Conventional Ruler Measurement.

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 Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells.

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). 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.

A Prospective, Single-center, Open-label Case Series Evaluating the Clinical Outcomes of Lyopreserved Placental Membrane Containing Viable Cells in the Treatment of Chronic Wounds.

Introduction: Cryopreserved placental membrane containing viable cells (vCPM) in conjunction with standard of care (SOC) has shown clinical effectiveness in several studies for the management of acute and chronic wounds. Recently, a new lyophilization technique has been developed that allows viable tissues to be stored at room temperature as a structural and functional equivalent to vCPM.

Objective: This case series evaluates the clinical outcomes of a lyopreserved placental membrane containing viable cells (vLPM) for the management of chronic wounds of various etiologies.

Continuous Temperature-Monitoring Socks for Home Use in Patients With Diabetes: Observational Study.

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 diabetic foot ulcer (DFU) in their lifetime. Unresolved DFUs may lead to sepsis and are the leading cause of lower-limb amputations.

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.

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.

Human placental membrane as a wound cover for chronic diabetic foot ulcers: a prospective, postmarket, CLOSURE study.

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.

A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix ) allograft for the treatment of venous leg ulcers.

A randomised, controlled, multicentre clinical trial was conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft as an adjunct to multilayer compression therapy for the treatment of non-healing full-thickness venous leg ulcers. We randomly assigned 109 subjects to receive EpiFix and multilayer compression (n = 52) or dressings and multilayer compression therapy alone (n = 57). Patients were recruited from 15 centres around the USA and were followed up for 16 weeks.

Determinants of midterm functional outcomes, wound healing, and resources used in a hospital-based limb preservation program.

Objective: The objective of this study was to assess midterm functional status, wound healing, and in-hospital resource use among a prospective cohort of patients treated in a tertiary hospital, multidisciplinary Center for Limb Preservation.

Methods: Data were prospectively gathered on all consecutive admissions to the Center for Limb Preservation from July 2013 to October 2014 with follow-up data collection through January 2016. Limbs were staged using the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) threatened limb classification scheme at the time of hospital admission.

Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers.

Objective: We conducted a multicenter evaluation of a novel remote foot-temperature monitoring system to characterize its accuracy for predicting impending diabetic foot ulcers (DFU) in a cohort of patients with diabetes with previously healed DFU.

Research Design And Methods: We enrolled 132 participants with diabetes and prior DFU in this 34-week cohort study to evaluate a remote foot-temperature monitoring system (ClinicalTrials.gov Identifier NCT02647346).

Initial Report on the Use of In-Office Cone Beam Computed Tomography for Early Diagnosis of Osteomyelitis in Diabetic Patients.

Osteomyelitis is one of the most feared sequelae of diabetic foot ulceration, which often leads to lower-extremity amputation and disability. Early diagnosis of osteomyelitis increases the likelihood of successful treatment and may limit the amount of bone resected, preserving ambulatory function. Although a variety of techniques exist for imaging the diabetic foot, standard radiography is still the only in-office imaging modality used today.

A clinical trial of Integra Template for diabetic foot ulcer treatment.

Individuals with diabetes mellitus are at an increased risk of developing a diabetic foot ulcer (DFU). This study evaluated the safety and efficacy of Integra Dermal Regeneration Template (IDRT) for the treatment of nonhealing DFUs. The Foot Ulcer New Dermal Replacement Study was a multicenter, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption.

Evidence of Intensive Autolytic Debridement With a Self-Adaptive Wound Dressing.

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.

A Multicenter Randomized Controlled Trial Comparing Treatment of Venous Leg Ulcers Using Mechanically Versus Electrically Powered Negative Pressure Wound Therapy.

This study compares two different negative pressure wound therapy (NPWT) modalities in the treatment of venous leg ulcers (VLUs), the ultraportable mechanically powered (MP) Smart Negative Pressure (SNaP) Wound Care System to the electrically powered (EP) Vacuum-Assisted Closure (V.A.C.

Initial clinical assessment of a novel multifunctional topical ointment for difficult-to-heal wounds: a case series.

Chronic wounds are characterized by prolonged inflammation, bacterial bioburden, and ischemia. These factors represent the barriers to wound healing that need to be addressed in order to achieve wound closure. The authors performed the initial clinical testing of WinVivo Wound Ointment ("WinVivo"), a novel topical ointment containing several botanicals that have been previously shown to promote favorable wound environment and advance wound healing.