Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population

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 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)

Study Overview

• Status: Terminated
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: Membrane Wrap™; Other: Standard of Care

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 leg ulcers (VLUs). The primary objective is to evaluate the effectiveness of Membrane wrap™ versus Standard of Care (SOC) in subject with eligible venous leg ulcers.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Tital Clinical Research
  • California
    • San Franciso, California, United States, 94115
      • Center for Clinical Research
  • Florida
    • DeLand, Florida, United States, 32720
      • Midland Florida Clinical Research Center
    • North Miami Beach, Florida, United States, 33162
      • BioPhase Research
    • South Miami, Florida, United States, 33143
      • Doctors Research Network
  • Illinois
    • O'Fallon, Illinois, United States, 62269
      • Gateway Clinical Trials
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health
  • Ohio
    • Cleveland, Ohio, United States, 44013
      • Kent State College of Podiatry
  • Texas
    • Houston, Texas, United States, 77074
      • Advantage Foot Care of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1- Membrane-Wrap™ plus SOC; Membrane-Wrap ™ plus SOC Group 1 plus SOC treatment will be defined as: 1) debridement of non-viable, necrotic tissue, 2) application of Biologic as the primary, wound covering, 3) application of a dressing over Biologic that maintains moisture balance, 4) application of a Class 3 high compression system. A Class 3 high-compression system is required. High compression is useful for bigger legs or more active patients. High compression wraps can be used over padding on their own or as part of a layered system and should be applied in a spiral according to manufacturer's instructions. High strength compression can be applied successfully using many methods including but not limited to multilayered elastic compression, inelastic compression, Unna's boot, compression stockings, and other	Device: Membrane Wrap™; Membrane Wrap™
Other: Group 2: SOC only; Group 2: Standard of Care only- Subjects randomized to Group 5 (SOC, or Active Control treatment) will not receive Biologic, but will receive SOC alone. SOC) is defined as: Compression treatment per Wound Healing Society guidelines, "Compression for treatment of Venous Ulcers" [10]. SOC, or Active Control treatment, is defined as: 1) debridement of non-viable, necrotic tissue, 2) application of a primary, wound contact dressing that maintains moisture balance, 3) application of a Class 3 high compression system, and 4) wrapping with a covering, tertiary dressing. A Class 3 (most supportive) high-compression system is required. High compression bandages provide and maintain high levels of compression pressures in the range 25-35 mm Hg at the ankle. High strength compression can be applied successfully using many methods including multilayered elastic compression, inelastic compression, Unna's boot, compression stockings, and other.	Other: Standard of Care; SOC treatment will be defined as: 1) debridement of non-viable, necrotic tissue, 2) application of Biologic as the primary, wound covering, 3) application of a dressing over Biologic that maintains moisture balance, 4) application of a Class 3 high compression system, and 5) wrapping with a covering dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to wound closure by or on week 12.	Wound Closure is defined as: Full epithelialization of the wound with the absence of drainage; Epithelialization is defined as a layer of epithelium visible on the wound surface	12 weeks
Frequency of wound closure by or on week 12.	Wound Closure is defined as: Full epithelialization of the wound with the absence of drainage; Epithelialization is defined as a layer of epithelium visible on the wound surface	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of VLU improvement by or on End of Study (EOS) from baseline	defined by: >60% reduction in area, or; >60% reduction in depth, or; >75% reduction in volume Rate of VLU improvement by or on End of Study (EOS) from baseline	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ulcer recurrence within the 12-week study period	Incidence of ulcer recurrence within the 12-week study period	12 weeks
Mean number of ulcer free days within the 12-week study period	Mean number of ulcer free days within the 12-week study period	12 weeks

Collaborators and Investigators

• Sponsor: BioLab Holdings
• Investigators: Study Chair: Marshall Medley, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Actual): July 10, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Skin and Connective Tissue Diseases; Varicose Ulcer; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: RCT-001-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No