Actively Recruiting
Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population
Led by BioLab Holdings · Updated on 2025-07-03
150
Participants Needed
9
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to assess the clinical effectiveness of Membrane Wrap, a human amniotic membrane for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs)
CONDITIONS
Official Title
Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ulcers must be of venous origin confirmed by clinical signs or tests
- Ulcers must have lasted at least 1 month without adequate response to conventional therapy
- Ulcer size between 2 cm² and 16 cm²
- Ulcer area must not have decreased by 40% or more during the 2-week screening
- Ulcers may be partial- or full-thickness involving epidermis and dermis
- Participants must be between 50 and 85 years old
- Participants must be available for 12-week follow-up
- Participants or their legal representative must have signed informed consent
You will not qualify if you...
- Ankle Brachial Index less than 0.7 or Toe Brachial Index less than 0.5
- Vasculitis, severe rheumatoid arthritis, or other collagen vascular diseases
- Medical conditions impairing wound healing such as kidney, liver, blood, nerve, or immune diseases
- Signs of infection, cellulitis, or bone infection (osteomyelitis)
- Necrotic ulcer beds
- Receiving hemodialysis or uncontrolled diabetes with A1C 12 or higher
- Use of corticosteroids (>15 mg/day), immunosuppressants, radiation therapy, or chemotherapy within 1 month prior to study
- Ulcer unable to be debrided or participant cannot tolerate debridement
- Unwilling or unable to comply with compression therapy
- Participation in other wound or device studies within past 3 months or 30 days respectively
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Tital Clinical Research
Mesa, Arizona, United States, 85202
Actively Recruiting
2
Center for Clinical Research
San Francisco, California, United States, 94115
Actively Recruiting
3
Midland Florida Clinical Research Center
DeLand, Florida, United States, 32720
Actively Recruiting
4
Biophase Research
North Miami Beach, Florida, United States, 33162
Actively Recruiting
5
Doctors Research Network
South Miami, Florida, United States, 33143
Actively Recruiting
6
Gateway Clinical Trials
O'Fallon, Illinois, United States, 62269
Actively Recruiting
7
Northwell Health
Lake Success, New York, United States, 11042
Actively Recruiting
8
Kent State College of Podiatry
Cleveland, Ohio, United States, 44013
Actively Recruiting
9
Advantage Foot Care of Houston
Houston, Texas, United States, 77074
Actively Recruiting
Research Team
M
Marshall Medley
CONTACT
C
Carlos Encinas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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