Status:
RECRUITING
Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population
Lead Sponsor:
BioLab Holdings
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
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)
Detailed Description
Multi-center (up to 20 sites), prospective, randomized trial assess the clinical effectiveness of human amniotic membrane(s) for the management of difficult to heal partial- or full-thickness venous l...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- Ulcers of venous origin, as determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test). If the subject has multiple on the same leg and/or bilateral ulcers, the largest should be selected.
- Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
- Venous insufficiency ulcers between 2 cm2 and 16 cm2
- Venous ulcer has not reduced in area ≥40% from baseline measurements during the 2-week screening period
- Partial- or full-thickness VLU, including ulcers with tissue damage that extends through the epidermis and into the upper epidermis (papillary dermis), or into the deep dermis
- Subjects are between 50 and 85 years of age.
- Subject is expected to be available for 12-week follow-up
- Subject, or their Legally Authorized Representative (LAR), has read, understood, and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.
- Subjects who meet any of the following criteria will be excluded from participating in this study:
- Ankle Brachial Index (ABI) of \<0.7 or Toe Brachial Index (TBI) \<0.5
- Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases
- Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease
- Signs and symptoms of infection, cellulitis, osteomyelitis
- Necrotic ulcer beds
- Subjects receiving hemodialysis or have uncontrolled diabetes: defined as A1C of greater than or equal to 12. An existing A1C value is allowed if completed within 3 months of subject screening.
- Subjects who are currently receiving or have received at any time within one month prior to entry into the study, corticosteroids (\>15 mg/day), immunosuppressive agents, radiation therapy, or chemotherapy. Anticipated use of the above agents will exclude subjects from entry into the study.
- Wound unable to be debrided or subject not able to tolerate debridement
- Subject not willing or able to comply with compression requirements
- Subjects enrolled in other wound investigational studies within the past three months, or device studies within the past 30 days.
Exclusion
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06544564
Start Date
March 31 2025
End Date
September 30 2026
Last Update
July 3 2025
Active Locations (9)
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1
Tital Clinical Research
Mesa, Arizona, United States, 85202
2
Center for Clinical Research
San Francisco, California, United States, 94115
3
Midland Florida Clinical Research Center
DeLand, Florida, United States, 32720
4
Biophase Research
North Miami Beach, Florida, United States, 33162