Clinical Trial for Non-Healing Foot and Leg Ulcers
This study is looking at new ways to help non-healing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) close. It compares standard care (like cleaning and dressing wounds) to standard care plus two different human placental membrane products, called AM/Single and AM/Double. The goal is to see if these products help ulcers heal faster over 12 weeks. You may be able to join if you are at least 18 years old, have type 1 or 2 diabetes, and have a DFU or VLU within a specific size range. The study is currently recruiting about 177 participants, but its exact status is unclear.
- Study design
- This is a multicenter, randomized controlled study designed to compare different treatments. It plans to enroll about 177 participants.
- What's involved
- You would receive weekly treatments, which include standard care (cleaning, debridement, and managing moisture or compression) and possibly applications of AM/Single or AM/Double, for up to 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is to measure ulcer closure over 12 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Thomas Serena, MD · PRINCIPAL_INVESTIGATOR · SerenaGroup, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Determine the percentage of subjects achieving complete closure of target ulcer over 12 weeks.1-12 weeks
The proportion of subjects achieving complete wound closure of target ulcer.