Venous Leg Ulcer (VLU)NCT07078968
A Real World Data Collection of Human Amniotic Membrane(s) on Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Ulcers and Post Operative Wounds
An observational study of Venous Leg Ulcer (VLU) and Diabetic Foot Ulcer (DFU), run by BioLab Holdings at 4 sites in United States.
Trial summary
This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
- What is being tested?
- Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Apr 2025to 1 Oct 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with difficult to heal partial- or full-thickness diabetic foot ulcers (DFU), venous leg ulcers (VLU), pressure ulcers (PU), and post-operative wounds defined as an ulcer that has not healed with conventional therapy for ≥ 4 weeks.
Who may be able to join
- Subject had the presence of diabetic foot ulcers, Venous insufficiency ulcers, pressure ulcers and/or post-operative wounds
- Subject has retrospectively been treated with Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ or Subject has retrospectively been treated with Standard of Care only.
- Subjects should have been treated from January 2022 to present day.
Who cannot join
- Subjects that did not have a wound closure verification appointment.
- Any subject who received any product other than Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ during their treatment time.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Houston Foot and Ankle Care
Houston, Texas, 77027
Houston Foot Dr
Houston, Texas, 77095
Athena Specialty Group
Phoenix, Arizona, 85048
Revive Advanced Wound Care
Toms River, New Jersey, 08755
About this study
This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection.
Read the detailed description
This is a retrospective multi-center study collecting real world evidence on the use of Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™ and Standard of Care alone in subjects with eligible DFUs, VLUs, PUs, and post operative wounds that have not healed with conventional therapy for greater than or equal to 4 weeks.
- Being tested
- Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™, Standard of Care
- Medical subject headings
- Varicose Ulcer, Diabetic Foot, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-Membrane Wrap™Device
Membrane Wrap™
Membrane Wrap™Device
Membrane Wrap™
Membrane Wrap-Hydro™Device
Membrane Wrap-Hydro™
Standard of CareOther
Basic care involves debridement, along with local wound care depending on the wound needs. Debridement involves removal of fibrin and devitalized tissue from the base and the borders of the ulcer which is necessary in all treatment plans to reduce the risk of infection and promote healing.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Amniotic Membrane | De-Identified subject data will be extracted from investigators' medical records for subjects who received Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™ plus SOC in subjects with eligible DFUs, VLUs, PUs and post operative wounds Receives: Device: Tri-Membrane Wrap™; Device: Membrane Wrap™; Device: Membrane Wrap-Hydro™ | |
| Group 2 SOC | De-identified subject data will be extracted from investigators' medical records who were treated with only Standard of Care with eligible DFUs, VLUs, PUs and post operative wounds. Subjects in the SOC may have received hyperbaric or wound vac therapies as part of their treatments. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of wound closure by or on week 16
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: 16 weeks
Secondary outcomes (3)
Wound 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
Measured: 16 weeks
Incidence of wound recurrence within the 16-week study period
Incidence of wound recurrence within the 16-week study period
Measured: 16 weeks
Mean number of wound free days within the 16-week study period
Mean number of wound free days within the 16-week study period
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start23 Apr 2025
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg Ulcer (VLU)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 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
- NCT07078968
- Sponsor's protocol ID
- RWE-001-25
- Status last verified
- May 2026
- First submitted
- 14 Jul 2025
- Last updated
- 1 Oct 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Data Collection of Human Amniotic Membrane(s) on Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Ulcers and Post Operative Wounds
- ClinicalTrials.gov ID
- NCT07078968
- Acronym / sponsor ID
- RWE-001-25
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- BioLab HoldingsIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 22 Jul 2025 (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 evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection.
Detailed description
This is a retrospective multi-center study collecting real world evidence on the use of Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™ and Standard of Care alone in subjects with eligible DFUs, VLUs, PUs, and post operative wounds that have not healed with conventional therapy for greater than or equal to 4 weeks.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Amniotic Membrane | – | Device: Tri-Membrane Wrap™, Device: Membrane Wrap™, Device: Membrane Wrap-Hydro™De-Identified subject data will be extracted from investigators' medical records for subjects who received Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™ plus SOC in subjects with eligible DFUs, VLUs, PUs and post operative wounds |
| Group 2 SOC | – | Other: Standard of CareDe-identified subject data will be extracted from investigators' medical records who were treated with only Standard of Care with eligible DFUs, VLUs, PUs and post operative wounds. Subjects in the SOC may have received hyperbaric or wound vac therapies as part of their treatments. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with difficult to heal partial- or full-thickness diabetic foot ulcers (DFU), venous leg ulcers (VLU), pressure ulcers (PU), and post-operative wounds defined as an ulcer that has not healed with conventional therapy for ≥ 4 weeks.
Key inclusion criteria (3 listed)
- Subject had the presence of diabetic foot ulcers, Venous insufficiency ulcers, pressure ulcers and/or post-operative wounds
- Subject has retrospectively been treated with Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ or Subject has retrospectively been treated with Standard of Care only.
- Subjects should have been treated from January 2022 to present day.
Key exclusion criteria (2 listed)
- Subjects that did not have a wound closure verification appointment.
- Any subject who received any product other than Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ during their treatment time.
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 |
|---|---|---|
| Tri-Membrane Wrap™Membrane Wrap™ | Device | Group 1 Amniotic Membrane |
| Membrane Wrap™Membrane Wrap™ | Device | Group 1 Amniotic Membrane |
| Membrane Wrap-Hydro™Membrane Wrap-Hydro™ | Device | Group 1 Amniotic Membrane |
| Standard of CareBasic care involves debridement, along with local wound care depending on the wound needs. Debridement involves removal of fibrin and devitalized tissue from the base and the borders of the ulcer which is necessary in all treatment plans to reduce the risk of infection and promote healing. | Other | Group 2 SOC |
Primary outcome
Frequency of wound closure by or on week 16
Time frame: 16 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
3 secondary outcomes
Wound improvement by or on End of Study (EOS) from baseline
Time frame: 16 weeks
Incidence of wound recurrence within the 16-week study period
Time frame: 16 weeks
Mean number of wound free days within the 16-week study period
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Leg Ulcer (VLU) and Diabetic Foot Ulcer (DFU), run by BioLab Holdings at 4 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of wound closure by or on week 16 (time frame: 16 weeks). 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 1 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.