Study for Diabetic Foot and Venous Leg Ulcers
This study is testing different treatments for non-healing diabetic foot ulcers (DFU) and venous leg ulcers (VLU). You might receive standard care (cleaning, debridement, moisture balance, and offloading for DFU or compression for VLU) alone, or standard care combined with AmnioCore, Amnio Quad-Core (for DFU), or Amnio Tri-Core (for VLU). Researchers want to see if these combined treatments help ulcers close completely over 12 weeks compared to standard care alone. To join, you must be at least 21 years old, have type 1 or 2 diabetes, and have a target ulcer between 1.0 and 5.0 cm² after cleaning. The current recruitment status is unclear.
- Study design
- This is a randomized controlled study involving 324 participants. It compares several treatments (AmnioCore, Amnio Quad-Core, Amnio Tri-Core) combined with standard care against standard care alone.
- What's involved
- You would receive weekly treatments for up to 13 weeks, or until your ulcer closes. This includes cleaning, debridement, and specific applications depending on your assigned group.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal is to measure differences in ulcer closure between 1 and 12 weeks after starting treatment.
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 Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Determine the between-arm difference1-12 Weeks
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design.