CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations

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

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

Conditions4

Locations7 sites

Browse More Trials