Clinical trial NCT06544564: Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: BioLab Holdings
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 parallel groups randomly assigned in a 1:1 fashion
Primary purpose: TREATMENT

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)

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.

Eligibility 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.

Primary outcomes:
measure: Time to wound closure by or on week 12.
timeFrame: 12 weeks
measure: Frequency of wound closure by or on week 12.
timeFrame: 12 weeks
Secondary outcomes:
measure: Rate of VLU improvement by or on End of Study (EOS) from baseline
timeFrame: 12 weeks
Other outcomes:
measure: Incidence of ulcer recurrence within the 12-week study period
timeFrame: 12 weeks
measure: Mean number of ulcer free days within the 12-week study period
timeFrame: 12 weeks
Locations:
city: Mesa
country: United States
facility: Tital Clinical Research
state: Arizona
city: San Francisco
country: United States
facility: Center for Clinical Research
state: California
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center
state: Florida
city: North Miami Beach
country: United States
facility: Biophase Research
state: Florida
city: South Miami
country: United States
facility: Doctors Research Network
state: Florida
city: O'Fallon
country: United States
facility: Gateway Clinical Trials
state: Illinois
city: Cleveland
country: United States
facility: Kent State College of Podiatry
state: Ohio
city: Houston
country: United States
facility: Advantage Foot Care of Houston
state: Texas
Study officials:
affiliation: Sponsor GmbH
name: Marshall Medley
role: STUDY_CHAIR
References: