NCT07046767 CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
| NCT ID | NCT07046767 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Capsicure, LLC |
| Condition | Diabetic Foot Ulcer (DFU) |
| Study Type | INTERVENTIONAL |
| Enrollment | 165 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-07-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 165 participants in total. It began in 2025-10-01 with a primary completion date of 2026-07-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics
Contact & Investigator
Windy Cole, DPM
STUDY DIRECTOR
Capsicure, LLC
Frequently Asked Questions
Who can join the NCT07046767 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Foot Ulcer (DFU). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07046767 currently recruiting?
Yes, NCT07046767 is actively recruiting participants. Contact the research team at mdocter@capsicure.com for enrollment information.
Where is the NCT07046767 trial being conducted?
This trial is being conducted at Oxnard, United States, Coral Gables, United States, Miami, United States, Indianapolis, United States and 3 additional locations.
Who is sponsoring the NCT07046767 clinical trial?
NCT07046767 is sponsored by Capsicure, LLC. The principal investigator is Windy Cole, DPM at Capsicure, LLC. The trial plans to enroll 165 participants.