CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations (NCT07046767) | Clinical Trial Compass
RecruitingNot Applicable
CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
United States165 participantsStarted 2025-10-01
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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