Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population

NCT06544564 | Recruiting FDA Device

• 1 other identifier: RCT-001-24
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 9

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)

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Rate of VLU improvement by or on End of Study (EOS) from baseline

  12 weeks

Other Outcomes (2)

• Incidence of ulcer recurrence within the 12-week study period

  12 weeks

• Mean number of ulcer free days within the 12-week study period

  12 weeks

Study Arms (2)

Group 1- Membrane-Wrap™ plus SOC

EXPERIMENTAL

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™

Group 2: SOC only

OTHER

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

Interventions

Membrane Wrap™ DEVICE

Membrane Wrap™

Group 1- Membrane-Wrap™ plus SOC

Standard of Care OTHER

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

Group 2: SOC only

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• BioLab Holdings: lead

Study Sites (9)

Tital Clinical Research

Mesa, Arizona, 85202, United States

RECRUITING

Center for Clinical Research

San Francisco, California, 94115, United States

RECRUITING

Midland Florida Clinical Research Center

DeLand, Florida, 32720, United States

RECRUITING

Biophase Research

North Miami Beach, Florida, 33162, United States

RECRUITING

Doctors Research Network

South Miami, Florida, 33143, United States

RECRUITING

Gateway Clinical Trials

O'Fallon, Illinois, 62269, United States

RECRUITING

Northwell Health

Lake Success, New York, 11042, United States

RECRUITING

Kent State College of Podiatry

Cleveland, Ohio, 44013, United States

RECRUITING

Advantage Foot Care of Houston

Houston, Texas, 77074, United States

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marshall Medley

  Sponsor GmbH

  STUDY CHAIR

Central Study Contacts

Marshall Medley

CONTACT

602-830-5107; mmedley@biolabholdings.net

Carlos Encinas

CONTACT

602-830-5106; cencinas@biolabholdings.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 parallel groups randomly assigned in a 1:1 fashion

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 9, 2024
• Study Start: March 31, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)