Venous Leg UlcerNCT06544564
Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population
A study testing Membrane Wrap™ in people with Venous Leg Ulcer, run by BioLab Holdings at 9 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Membrane Wrap™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 9 sitesUnited States
- Study dates
- 31 Mar 2025to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- 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.
- Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
- Venous insufficiency ulcers between 2 cm2 and 16 cm2
- Venous ulcer has not reduced in area ≥40% from baseline measurements during the 2-week screening period
- 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
Show all 20Show fewer
- Subjects are between 50 and 85 years of age.
- 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.
- Subjects who meet any of the following criteria will be excluded from participating in this study:
- Ankle Brachial Index (ABI) of <0.7 or Toe Brachial Index (TBI) <0.5
- Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases
- Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease
- Signs and symptoms of infection, cellulitis, osteomyelitis
- Necrotic ulcer beds
- 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.
- 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.
- Wound unable to be debrided or subject not able to tolerate debridement
- Subject not willing or able to comply with compression requirements
- Subjects enrolled in other wound investigational studies within the past three months, or device studies within the past 30 days.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Kent State College of Podiatry
Cleveland, Ohio, 44013
Midland Florida Clinical Research Center
DeLand, Florida, 32720
Advantage Foot Care of Houston
Houston, Texas, 77074
Northwell Health
Lake Success, New York, 11042
Tital Clinical Research
Mesa, Arizona, 85202
Biophase Research
North Miami Beach, Florida, 33162
Gateway Clinical Trials
O'Fallon, Illinois, 62269
Center for Clinical Research
San Franciso, California, 94115
Doctors Research Network
South Miami, Florida, 33143
About this study
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
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)
Read the 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.
- Conditions
- Venous Leg Ulcer
- Being tested
- Membrane Wrap™, Standard of Care
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Membrane Wrap™Device
Membrane Wrap™
Standard of CareOther
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, and 5) wrapping with a covering dressing
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Membrane-Wrap™ plus SOC | Experimental | 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 Receives: Device: Membrane Wrap™ |
| Group 2: SOC only | Other | 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to wound closure by or on week 12.
Wound Closure is defined as:
- Full epithelialization of the wound with the absence of drainage
- Epithelialization is defined as a layer of epithelium visible on the wound surface
Measured: 12 weeks
Frequency of wound closure by or on week 12.
Wound Closure is defined as:
- Full epithelialization of the wound with the absence of drainage
- Epithelialization is defined as a layer of epithelium visible on the wound surface
Measured: 12 weeks
Secondary outcomes (1)
Rate of VLU improvement by or on End of Study (EOS) from baseline
defined by:
- >60% reduction in area, or
- >60% reduction in depth, or
- >75% reduction in volume Rate of VLU improvement by or on End of Study (EOS) from baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start31 Mar 2025
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parallel groups randomly assigned in a 1:1 fashion
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioLab Holdings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marshall Medley, Study chair, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544564
- Sponsor's protocol ID
- RCT-001-24
- Status last verified
- May 2026
- First submitted
- 31 Jul 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06544564
- Acronym / sponsor ID
- RCT-001-24
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BioLab HoldingsIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 parallel groups randomly assigned in a 1:1 fashion
| Arm | Type | Receives |
|---|---|---|
| Group 1- Membrane-Wrap™ plus SOC | Experimental | Device: Membrane Wrap™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 |
| Group 2: SOC only | Other | Other: Standard of CareGroup 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- 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.
- Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
- Venous insufficiency ulcers between 2 cm2 and 16 cm2
- Venous ulcer has not reduced in area ≥40% from baseline measurements during the 2-week screening period
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Membrane Wrap™Membrane Wrap™ | Device | Group 1- Membrane-Wrap™ plus SOC |
| Standard of CareSOC 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, and 5) wrapping with a covering dressing | Other | Group 2: SOC only |
Primary outcome
Time to wound closure by or on week 12.
Time frame: 12 weeks
Wound Closure is defined as: * Full epithelialization of the wound with the absence of drainage * Epithelialization is defined as a layer of epithelium visible on the wound surface
Frequency of wound closure by or on week 12.
Time frame: 12 weeks
Wound Closure is defined as: * Full epithelialization of the wound with the absence of drainage * Epithelialization is defined as a layer of epithelium visible on the wound surface
1 secondary outcome
Rate of VLU improvement by or on End of Study (EOS) from baseline
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marshall Medley study chair
Sponsor GmbH
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Membrane Wrap™ in people with Venous Leg Ulcer, run by BioLab Holdings at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to wound closure by or on week 12. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.