Diabetic Foot Ulcer Clinical Trials

The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers. Read Less

The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design. Read Less

A Phase 2a Multi-Center, Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU) Read Less

This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amniotic Membrane (BR-AM) plus standard of care versus standard of care only in the treatment of diabetic foot ulcers. The trial design will control potential variables that may affect the outcome between the treatment group and the control group by standardizing the requirements for debridement, wound dressings, and offloading. Weekly subject visits will help monitor compliance in wound care and off-loading, as well as to document when wound closure is achieved. The study will also implement the use of an electronic imaging and measurement device using a standardized protocol to ensure the measuring of the wound surface area and volume is accurate, highly reproducible, and minimally variable. There will also be a crossover treatment phase for those patients that were relegated to standard care only. After their 12-week standard of care treatment phase and for only those subjects that did not achieve complete wound closure, will be allowed to crossover for an additional 12 weeks of treatment with the BR-AM product following the protocol and procedures set forth within this document. Read Less

The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment. Read Less

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers. Read Less

People with diabetes often experience foot ulcers, which can harm their ability to move, lower their quality of life, and increase the chances of losing a limb. These diabetic foot ulcers (DFUs) commonly come back (recur) even after they've healed, so it's crucial to stop them from returning to avoid toe, foot , or leg amputation. While wearing special shoes to reduce pressure on the feet is essential for healing and preventing DFUs, many people struggle to follow this treatment plan once their ulcers have healed. This study aims to see if a lifestyle-focused program can help participants create daily routines and habits that make it easier to consistently use special shoes and take care of their diabetes and feet to prevent ulcers from recurring. Read Less

The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot. Read Less

The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2, mild to moderate, neuroischemic diabetic chronic foot ulcers in subjects with Type 1 and Type 2 Diabetes Mellitus. The main question\[s\] it aims to answer \[is/are\]: Measure 1: Wound Closure with Tropocells Autologous PRF System for DFU Measure 2: Safety of Tropocells Autologous PRF System for DFU Researchers will enroll to acquire approximately 30 evaluable subjects with no comparison group. Run-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, for standard of care. Active Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic to receive standard of care with Tropocells Autologous PRF System. Follow-up Phase (1 month and 3 months): participants with wounds that losed during the Active Treatment Phase ( 100% wound closure with two weekly assessments demonstrating persistent closure) will be advanced to the follow-up phase to show if the wound remains closed at 1 month and 3 months. Read Less

The overarching purpose of this study is to investigate the impact that exercise, as delivered through a medically supervised, outpatient cardiac rehabilitation program, has on the wound healing process in Type 2 diabetics having foot ulcers classified as being Wound, Ischemia, foot Infection (WIfI) stage 2 or lower. The criterion reference measure of diabetic foot ulcer wound healing is be the time required to reach the maturation phase of the wound healing cascade (wound closure without drainage). Read Less

This study is being done to collect data from treatment of patients who have diabetes with non-healing foot wounds and are being treated with a resorbable and biocompatible borate-based bioactive glass fiber matrix. A borate-based bioactive glass fiber matrix is used to cover the ulcer for wound management. The primary objective of this study is to evaluate the safety and efficacy of the borate-based bioactive glass fiber matrix in the treatment of diabetic foot ulcers in a real-world setting. The secondary objective is to evaluate the clinical and financial benefits in terms of quality of healing, pain, and treatment cost. Read Less

A Pilot Study to Determine the Impact of the Phoenix Wound Matrix® on the Wound Microbiome in Chronic Diabetic Foot Ulcers Read Less