Membrane Wrap for Venous Leg Ulcers

Recruiting at 7 trial locations

Overseen By Marshall Medley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BioLab Holdings

Must not be taking: Corticosteroids, Immunosuppressants, Chemotherapy, others

Disqualifiers: Vasculitis, Rheumatoid arthritis, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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)

Research Team

Marshall Medley

Principal Investigator

Sponsor GmbH

Eligibility Criteria

This trial is for people aged 50-85 with venous leg ulcers that haven't improved much in the last month despite treatment. The ulcers should be between 2 cm² and 32 cm², not healing well over a two-week check, and not deeper than the muscles or bone. Participants must understand and sign a consent form and be available for follow-up for three months.

Inclusion Criteria

My venous ulcer has not shrunk by 40% or more in the last 2 weeks.

Subject is expected to be available for 12-week follow-up

I am between 50 and 85 years old.

Exclusion Criteria

Ankle Brachial Index (ABI) of <0.7 or Toe Brachial Index (TBI) <0.5

I have a health condition that could affect how my wounds heal.

I have open sores with dead tissue.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Membrane-Wrap™ plus SOC or SOC alone for venous leg ulcers

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Membrane Wrap™

Trial Overview The study tests Membrane Wrap™ against standard care to see if it's better at treating tough venous leg ulcers. It looks at how well these partial- or full-thickness wounds heal when wrapped in this human amniotic membrane product.

Participant Groups

Group I: Group 2: SOC only Experimental Treatment 1 Intervention

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.

Group II: Group 1- Membrane-Wrap™ plus SOC Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

BioLab Holdings

Lead Sponsor

Trials

1

Recruited

380+