Using human amniotic membrane to treat venous leg ulcers in older adults
A Multi-Center, Prospective, Randomized Trial Evaluating the Efficacy of Membrane Wrap, A Human Amniotic Membrane on Venous Leg Ulcers in an Elderly Population
This study is testing if a new treatment using human amniotic membrane can help older adults heal stubborn venous leg ulcers better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | BioLab Holdings Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 9 sites (Mesa, Arizona and 8 other locations) |
| Trial ID | NCT06544564 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Membrane Wrap, a human amniotic membrane, in treating difficult-to-heal venous leg ulcers (VLUs) in an elderly population. Conducted across multiple centers, the trial is randomized and compares the outcomes of patients receiving Membrane Wrap to those receiving standard care. Participants must have venous ulcers that have not responded adequately to conventional treatments and meet specific size and duration criteria. The primary goal is to determine if the Membrane Wrap can significantly improve healing rates compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals aged 50 to 85 with venous leg ulcers that have not improved with standard care.
Not a fit: Patients with ulcers of non-venous origin or those who do not meet the specified size and duration criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for healing chronic venous leg ulcers in elderly patients.
How similar studies have performed: Previous studies have shown promise in using human amniotic membranes for wound healing, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study, subjects must meet all of the following criteria: 1. 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. 2. Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy 3. Venous insufficiency ulcers between 2 cm2 and 16 cm2 4. Venous ulcer has not reduced in area ≥40% from baseline measurements during the 2-week screening period 5. 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 6. Subjects are between 50 and 85 years of age. 7. Subject is expected to be available for 12-week follow-up 8. 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: 1. Ankle Brachial Index (ABI) of \<0.7 or Toe Brachial Index (TBI) \<0.5 2. Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases 3. Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease 4. Signs and symptoms of infection, cellulitis, osteomyelitis 5. Necrotic ulcer beds 6. 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. 7. 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. 8. Wound unable to be debrided or subject not able to tolerate debridement 9. Subject not willing or able to comply with compression requirements 10. Subjects enrolled in other wound investigational studies within the past three months, or device studies within the past 30 days.
Where this trial is running
Mesa, Arizona and 8 other locations
- Tital Clinical Research — Mesa, Arizona, United States (Recruiting)
- Center for Clinical Research — San Francisco, California, United States (Recruiting)
- Midland Florida Clinical Research Center — DeLand, Florida, United States (Recruiting)
- Biophase Research — North Miami Beach, Florida, United States (Recruiting)
- Doctors Research Network — South Miami, Florida, United States (Recruiting)
- Gateway Clinical Trials — O'Fallon, Illinois, United States (Recruiting)
- Northwell Health — Lake Success, New York, United States (Recruiting)
- Kent State College of Podiatry — Cleveland, Ohio, United States (Recruiting)
- Advantage Foot Care of Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Marshall Medley
- Email: mmedley@biolabholdings.net
- Phone: 602-830-5107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.