CAMP RWE Trial: Amnion Grafts for Hard-to-Heal Ulcers
This study is looking at how well two types of BioLab Membrane Wrap, called BioLab Membrane Wrap Lite and BioLab Tri-Membrane Wrap, help heal hard-to-heal ulcers. These wraps are made from amniotic membrane (a part of the placenta) and are used as a protective covering for wounds. The study is for people aged 18 and older who have diabetic foot ulcers (DFUs) or venous leg ulcers that haven't healed much in the last four weeks. Your wound needs to be between 2 and 25 square centimeters in size. The main goal is to see if these wraps help your wound close completely within 12 weeks. The study aims to understand how these treatments work in real-world settings for a diverse group of patients.
- Study design
- This is a multicenter study comparing two different amnion grafts to a group of patients who received standard care in the past. It plans to include 165 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures wound closure at 12 weeks, which indicates a follow-up period of at least 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.
CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
At a glance
Conditions
Where it's being run
7 sites across 6 statesStudy leadership
- Windy Cole, DPM · STUDY_DIRECTOR · Capsicure, LLC
Who to contact
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What this trial measures
- Wound Closure12 Weeks
To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting wound healing compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care. Thus, the incidence of index ulcers obtaining complete wound closure by 12 weeks will be collected.