Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population

Stopped early · Not applicable

Conditions studied: Venous Leg Ulcer

In brief

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)

Key facts

Study ID: NCT06544564
Run by: BioLab Holdings
People needed: 30
Starts: 2025-03-31
Expected to finish: 2025-07-10
Last updated by the study team: 2026-05-27

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

Where it is running

Tital Clinical Research — Mesa, Arizona, United States
Center for Clinical Research — San Franciso, California, United States
Midland Florida Clinical Research Center — DeLand, Florida, United States
Biophase Research — North Miami Beach, Florida, United States
Doctors Research Network — South Miami, Florida, United States
Gateway Clinical Trials — O'Fallon, Illinois, United States
Northwell Health — Lake Success, New York, United States
Kent State College of Podiatry — Cleveland, Ohio, United States
Advantage Foot Care of Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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