Study for Hard-to-Heal Diabetic Foot Ulcers
This study is looking at new ways to help hard-to-heal diabetic foot ulcers (sores on the foot caused by diabetes) close. It compares four different products – Revita, Relese, Cogenex, and Enverse – each used with standard care (like cleaning and special shoes) to standard care alone. The goal is to see which treatment helps ulcers heal completely within 12 weeks. You might be able to join if you are at least 18 years old, have type 1 or 2 diabetes, and have a foot ulcer that has been present for at least 4 weeks but no more than 52 weeks. The study plans to enroll 272 people.
- Study design
- This study is a randomized, controlled trial involving multiple centers. It uses a unique design to test four different products at once, with a total of 272 participants planned.
- What's involved
- If you join, you will receive weekly treatments, which include standard care and possibly one of the study products. This will continue until your ulcer closes or for a maximum of 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal of the study is to see if ulcers close within 1 to 12 weeks, which suggests follow-up during this period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
At a glance
Conditions
Where it's being run
5 sites across 3 statesWho to contact
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What this trial measures
- The percentage of target ulcers achieving complete wound closure1-12 weeks
Determine the percent of target ulcers achieving complete wound closure at 12 weeks. In addition, a qualified third-party clinician will independently confirm wound closure.