The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of
Wagner grade 2 diabetic foot ulcers.
This study is a prospective, multi-center, randomized controlled trial (RCT) designed to
assess the safety and efficacy of SkinTE with standard of care (SOC) dressings compared to
SOC dressings alone (wound debridement, collagen-alginate dressing, multi-layer compression
dressings, and offloading) in the treatment of Wagner grade 2 diabetic foot ulcers (DFUs)
ranging in size from 1 to 10 cm2. After being informed about the study and potential risks,
all patients giving written informed consent who meet eligibility criteria will undergo a
2-week screening period of SOC. Patients meeting eligibility criteria following the screening
period will be randomized in a single-blind manner (blinded evaluator with closure confirmed
by a blinded adjudicator) in a 1:1 ratio to SkinTE with SOC or SOC alone. Patients will be
followed weekly for 6 months for wound closure.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.