CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
Recruiting now · Not applicable
Conditions studied: Diabetic Foot Ulcer (DFU), Venous Leg Ulcer, Wound; Foot
In brief
CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs
Key facts
- Study ID
- NCT07046767
- Run by
- Capsicure, LLC
- People needed
- 165
- Starts
- 2025-10-01
- Expected to finish
- 2026-07-20
- Last updated by the study team
- 2025-10-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female 18 years of age and older
- 2. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of >4 weeks duration and visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks
- Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2
- If the subject has more than one eligible wound the largest wound will be selected (the index wound)
- Subject is able and willing to follow the protocol requirements
- Subject has signed informed consent
You may not qualify if…
- Inability to adhere to the study protocol or study visit schedule
- Pregnancy
- Child-bearing potential without appropriate contraception
- Lactation
- Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.
- Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)
- The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
- Known contraindications to the use of amniotic tissue grafts
- The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics
Where it is running
- FOMAT Medical Research — Oxnard, California, United States (enrolling)
- Solutions Medical Research — Coral Gables, Florida, United States (enrolling)
- Nova Medical Services - Research Division LLC — Miami, Florida, United States (enrolling)
- Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States (enrolling)
- St. Louis Foot and Ankle, LLC — St Louis, Missouri, United States (enrolling)
- Jevlos Health, Inc — Syosset, New York, United States (enrolling)
- Hope Vascular and Podiatry — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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