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OpenTrials
Completed

NCT Number: NCT07078968

A Real World Data Collection of Human Amniotic Membrane(s) on Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Ulcers and Post Operative Wounds.

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.

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Key information

Conditions

Venous Leg Ulcer (VLU) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcer (DFU) Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Pressure Ulcer Pressure Ulcer (PU) Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Athena Specialty Group, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Tri-Membrane Wrap™

Device

Membrane Wrap™

Membrane Wrap™

Device

Membrane Wrap™

Membrane Wrap-Hydro™

Device

Membrane Wrap-Hydro™

Standard of care

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Wound improvement by or on End of Study (EOS) from baseline

    Time frame: 16 weeks

    Defined by: >60% reduction in area, or >60% reduction in depth, or >75% reduction in volume

  2. Incidence of wound recurrence within the 16-week study period

    Time frame: 16 weeks

    Incidence of wound recurrence within the 16-week study period

  3. Mean number of wound free days within the 16-week study period

    Time frame: 16 weeks

    Mean number of wound free days within the 16-week study period

Sponsors and collaborators

Lead sponsor

BioLab Holdings

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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