Actively Recruiting
CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
Led by Capsicure, LLC · Updated on 2025-10-22
165
Participants Needed
7
Research Sites
41 weeks
Total Duration
On this page
Sponsors
C
Capsicure, LLC
Lead Sponsor
B
BioLab Holdings
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age and older
- Non-healing venous leg ulcer or diabetic foot ulcer of more than 4 weeks duration with less than 50% reduction in wound size in the last 4 weeks
- Wound size between 2 cm² and 25 cm²
- If multiple eligible wounds, the largest wound will be selected as the index wound
- Able and willing to follow protocol requirements
- Signed informed consent
You will not qualify if you...
- Inability to follow the study protocol or visit schedule
- Pregnancy
- Child-bearing potential without appropriate contraception
- Lactation
- Treatment of the wound with engineered tissue or scaffold materials within 30 days before first treatment
- Visible signs of wound improvement (50% reduction in surface area) within 4 weeks before enrollment
- Other conditions that may compromise safety as judged by the investigator
- Known contraindications to amniotic tissue grafts
- Signs of wound infection requiring antibiotic treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
FOMAT Medical Research
Oxnard, California, United States, 93030
Actively Recruiting
2
Solutions Medical Research
Coral Gables, Florida, United States, 33134
Actively Recruiting
3
Nova Medical Services - Research Division LLC
Miami, Florida, United States, 33176
Actively Recruiting
4
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
St. Louis Foot and Ankle, LLC
St Louis, Missouri, United States, 63128
Actively Recruiting
6
Jevlos Health, Inc
Syosset, New York, United States, 11791
Actively Recruiting
7
Hope Vascular and Podiatry
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
M
Marissa Docter, RN, BSN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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