RecruitingDiabetic Foot Ulcer (DFU)Venous Leg UlcerWound; Foot
CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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
Sponsor: Capsicure, LLC
You may qualify if…
- ✓ 1. Male or female 18 years of age and older
- ✓ 2. 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
- ✓ 3. Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2
- ✓ 4. If the subject has more than one eligible wound the largest wound will be selected (the index wound)
- ✓ 5. Subject is able and willing to follow the protocol requirements
- ✓ 6. Subject has signed informed consent
You may not qualify if…
- ✕ 1. Inability to adhere to the study protocol or study visit schedule
- ✕ 2. Pregnancy
- ✕ 3. Child-bearing potential without appropriate contraception
- ✕ 4. Lactation
- ✕ 5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.
- ✕ 6. 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)
- ✕ 7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
- ✕ 8. Known contraindications to the use of amniotic tissue grafts
Where it's recruiting
Source: ClinicalTrials.gov · NCT07046767 · last updated 2025-10-22