Membrane Wrap for Venous Leg Ulcers

Recruiting at 8 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Membrane Wrap™, made from human amniotic membrane, to aid in healing stubborn venous leg ulcers (open sores on the legs caused by poor blood flow). Participants will receive either the Membrane Wrap™ with standard care or just the standard care, which involves cleaning and bandaging the ulcer with high compression wraps. The goal is to determine if adding the Membrane Wrap™ enhances healing. Individuals with venous leg ulcers that have not healed well with regular treatment and have been present for at least a month might be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore a promising new treatment option for those with challenging ulcers.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on corticosteroids, immunosuppressive agents, or have had radiation or chemotherapy recently, you may not be eligible to participate.

What prior data suggests that the Membrane Wrap™ is safe for managing venous leg ulcers?

Research has shown that using a human amniotic membrane, such as Membrane Wrap, can safely treat wounds like venous leg ulcers. Studies have found that treatments like this heal more leg ulcers compared to standard care alone, indicating that Membrane Wrap is generally well-tolerated by patients.

While detailed information on specific side effects or problems with Membrane Wrap itself is limited, human amniotic membranes are often used in medical treatments and are usually considered safe. They aid in skin healing and are commonly applied to various types of wounds.

Overall, although specific data on side effects for Membrane Wrap is lacking, its use in similar treatments suggests it is likely safe for most people. Prospective trial participants should discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Membrane Wrap™ for venous leg ulcers because it introduces a biologic component to the standard treatment. Unlike the typical standard of care, which includes debridement, moisture-maintaining dressings, and high-compression wraps, Membrane Wrap™ adds a biologic layer as the primary wound covering. This biologic component has the potential to enhance healing by actively interacting with the wound environment, potentially accelerating recovery and improving outcomes. This innovation could represent a significant advancement for patients struggling with chronic venous leg ulcers.

What evidence suggests that Membrane Wrap™ is effective for venous leg ulcers?

Research has shown that Membrane Wrap, which uses a special layer from the human placenta, holds promise for treating venous leg ulcers. In this trial, participants in Group 1 will receive Membrane Wrap plus standard of care (SOC). Studies have found that when combined with regular treatment, this method healed more ulcers and did so faster than regular treatment alone. Another study found that patients felt better overall with this approach. The human placenta layer acts as a protective cover and may help wounds heal quicker. These findings suggest Membrane Wrap could be a strong option for managing hard-to-heal venous leg ulcers. ^{1 6 7 8 9}

Who Is on the Research Team?

Marshall Medley

Principal Investigator

Sponsor GmbH

Are You a Good Fit for This Trial?

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07089602

Trial Assessing the Efficacy of Human Placental Membrane ... The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12050365/

A Multicenter, Randomized, Controlled, Clinical Trial ... LPM and standard of care, significantly closed more venous leg ulcers and faster than standard of care alone and improved the quality of life for patients.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06544564

Human Amniotic Membrane On Venous Leg Ulcers In an ... The primary objective is to evaluate the effectiveness of Membrane wrap™ versus Standard of Care (SOC) in subject with eligible venous leg ulcers. Official ...

4. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39864&ver=2

Skin Substitute Grafts/Cellular and Tissue-Based Products ... This LCD covers skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) in ...

5. genesispub.org genesispub.org/accelerated-healing-of-diabetic-and-venous-ulcers-with-adjunctive-dehydrated-human-amniotic-membrane-a-real-world-retrospective-cohort-study-from-a-single-provider-practice

Accelerated Healing of Diabetic and Venous Ulcers with ... Accelerated Healing of Diabetic and Venous Ulcers with Adjunctive Dehydrated Human Amniotic Membrane: A Real-World Retrospective Cohort Study ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07078968?aggFilters=status:act,funderType:industry&viewType=Table&rank=3

Study Details | NCT07078968 | A REAL WORLD DATA ... A REAL WORLD DATA COLLECTION OF HUMAN AMNIOTIC MEMBRANE(S) ON DIABETIC FOOT ULCERS, VENOUS LEG ULCERS, PRESSURE ULCERS AND POST OPERATIVE WOUNDS.

7. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=39865

Skin Substitute Grafts/Cellular and Tissue-Based Products ... Overall, the results show that substantially more ulcers healed when treated with bilayer artificial skin than with dressings. There was inadequate evidence ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9885475/

A meta‐review of the impact of compression therapy on ... Improved venous return helps to reduce peripheral oedema and promotes lower limb wound healing. Published healing rates of VLU managed with CT ...

9. jvascsurg.org jvascsurg.org/article/S0741-5214(99)70076-5/fulltext

Healing rates and cost efficacy of outpatient compression ... Results: Of all the ulcers, 57% were healed at 10 weeks of treatment and 75% were healed at 16 weeks. Ultimately, 96% of the ulcers healed, and only 1 major ...