An observational study in Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU) and Pressure Ulcer (PU), sponsored by BioLab Holdings. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by BioLab Holdings · Observational
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.
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.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's enrollment of 500 is above the median of 131 across 47 observational studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →BioLab Holdings is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Device: Tri-Membrane Wrap™ · Device: Membrane Wrap™ · Device: Membrane Wrap-Hydro™
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.
Other: Standard of Care
Membrane Wrap™
Membrane Wrap™
Membrane Wrap-Hydro™
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.
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
Time frame: 16 weeks
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
Time frame: 16 weeks
Incidence of wound recurrence within the 16-week study period
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
Mean number of wound free days within the 16-week study period
Time frame: 16 weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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BioLab Holdings