A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Foundation DRS Solo as an Adjunct to Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers.
Samaritan Biologics
Summary
The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does FoundationDRS Solo, when used in conjunction with standard of care wound management techniques, result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment. One ulcer on each participant's foot will receive weekly applications of 1) FoundationDRS Solo and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.
Description
Patients with diabetes often develop ulcers on their lower extremities. While some ulcers can be managed using standard of care wound management techniques including debridement, moist dressings, infection control and off-loading, many develop into chronic, non-healing wounds. Chronic non-healing wounds can lead to higher risk of infection, amputation and decreased quality of life. Advanced wound therapies aim to promote rapid and complete healing of chronic wounds. Examples of an advanced wound therapies include scaffolds that contain and / or mimic the structure and function of the natural…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 1\. Subjects must be at least 18 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus requiring treatment with oral medications and/or insulin replacement therapy. 3. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement prior to randomization at treatment visit 1 (TV1). 4. The target ulcer must have been present for a minimum of 4 weeks and is unresponsive (defined by less than 50% wound area reduction) to standard wound care. 5. The…
Interventions
- OtherFoundationDRS Solo
FoundationDRS Solo is a porous, degradable composite scaffold composed of chitosan and chondroitin sulfate
- OtherStandard of Care
Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading
Location
- Alma Medical and Research ServicesHollywood, Florida