RECRUITING

Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A Multi-Center, Prospective, Randomized Trial Evaluating the Efficacy of Membrane Wrap, A Human Amniotic Membrane on Venous Leg Ulcers in an Elderly Population

Quick Facts

Study Start:2025-03-31

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06544564

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.
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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Marshall Medley

CONTACT

602-830-5107

mmedley@biolabholdings.net

Carlos Encinas

CONTACT

602-830-5106

cencinas@biolabholdings.net

Principal Investigator

Marshall Medley

STUDY_CHAIR

Sponsor GmbH

Study Locations (Sites)

Center for Clinical Research

San Francisco, California, 94115

United States

Biophase Research

North Miami Beach, Florida, 33162

United States

Doctors Research Network

South Miami, Florida, 33143

United States

Advantage Foot Care of Houston

Houston, Texas, 77074

United States

Collaborators and Investigators

Sponsor: BioLab Holdings

Marshall Medley, STUDY_CHAIR, Sponsor GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-31

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2025-03-31

Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

Venous Leg Ulcer