Human Amniotic Membrane(s) On Venous Leg Ulcers In an Elderly Population

BioLab Holdings

Status: Not yet enrolling

Conditions: Venous Leg Ulcer

Treatments: Device: Membrane Wrap - Hydro™; Device: CT-Shield™; Other: Standard of Care; Device: Membrane Wrap™; Device: Membrane-Wrap Lite™

Study type: Interventional

Funder types: Industry

Identifiers

NCT06544564

RCT-001-24

Details and patient eligibility

About

This study is designed to assess the clinical effectiveness of human amniotic membrane(s) for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs)

Full description

Multi-center (up to 25 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 lite™, CT Shield™, Membrane wrap™ and Membrane wrap hydro™ versus Standard of Care (SOC) in subject with eligible venous leg ulcers.

Enrollment: 375 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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).
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 32 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 (reticular dermis) but not through muscle, tendon, capsule, or into bone.
6. Subjects are between 50 and 85 years of age.
7. IRB approved Informed Consent Form is signed before screening and treatment.
8. Subject is expected to be available for 12-week follow-up
9. Subjects with bilateral ulcers may be enrolled.
10. Subject, or their Legally Authorized Representative (LAR), has read, understood, and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

Exclusion criteria

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) <.5
2. Venous insufficiency ulcers less than 2cm2 or greater than 32cm2
3. Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases
4. Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease
5. Signs and symptoms of infection, cellulitis, osteomyelitis
6. Necrotic ulcer beds
7. Ulcer with exposed bone or tendon
8. Subjects receiving hemodialysis or have uncontrolled diabetes: defined as A1C of ≤12.
9. 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.
10. Subjects enrolled in other wound drug investigational studies within the past three months, or device studies within the past 30 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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375 participants in 5 patient groups

Group 1- Membrane-Wrap Lite™ plus SOC

Experimental group

Description:

Membrane-Wrap Lite™ plus SOC Membrane- Wrap Lite™: is a human tissue allograft derived from amniotic membrane that provide structural tissue for use as a wound and protectant covering. It is a single-layer human tissue allograft, containing solely the amnion layer of Amniotic Membrane \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271. Group will receive the assigned biologic plus Compression treatment per Wound Healing Society guidelines "Compression for treatment of Venous Ulcers" SOC treatment

Treatment:

Device: Membrane-Wrap Lite™

Group 2- CT-Shield™ plus SOC

Experimental group

Description:

CT-Shield™ plus SOC- CT Shield™: is a human tissue allograft derived from the amniotic membrane that provides protection, coverage and shielding for connective tissue. It is a triple-layered human tissue allograft, containing amnion-chorion-amnion layers \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271. Group will receive the assigned biologic plus Compression treatment per Wound Healing Society guidelines "Compression for treatment of Venous Ulcers" SOC treatment

Treatment:

Device: CT-Shield™

Group 3: Membrane Wrap™ plus SOC

Experimental group

Description:

Group 3: Membrane Wrap™ plus SOC- Membrane Wrap™: is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. It is a human tissue allograft \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271.Group will receive the assigned biologic plus Compression treatment per Wound Healing Society guidelines "Compression for treatment of Venous Ulcers" SOC treatment

Treatment:

Device: Membrane Wrap™

Group 4: Membrane Wrap - Hydro™ plus SOC

Experimental group

Description:

Group 4: Membrane Wrap - Hydro™ plus SOC- Membrane Wrap Hydro™: is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. It is a saline-hydrated human tissue allograft \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271. Group will receive the assigned biologic plus Compression treatment per Wound Healing Society guidelines, "Compression for treatment of Venous Ulcers" SOC treatment

Treatment:

Device: Membrane Wrap - Hydro™

Group 5: SOC only

Other group

Description:

Group 5: 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.

Treatment:

Other: Standard of Care