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

NCT07078968 | Active Not Recruiting FDA Device

• 1 other identifier: RWE-001-25
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Venous Leg Ulcer (VLU); Diabetic Foot Ulcer (DFU); Pressure Ulcer (PU)

Outcome Measures

Primary Outcomes (1)

• 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

  16 weeks

Secondary Outcomes (3)

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

  16 weeks

• Incidence of wound recurrence within the 16-week study period

  16 weeks

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

  16 weeks

Study Arms (2)

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

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.

Other: Standard of Care

Interventions

Tri-Membrane Wrap™ DEVICE

Membrane Wrap™

Group 1 Amniotic Membrane

Membrane Wrap™ DEVICE

Membrane Wrap™

Group 1 Amniotic Membrane

Membrane Wrap-Hydro™ DEVICE

Membrane Wrap-Hydro™

Group 1 Amniotic Membrane

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.

Group 2 SOC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioLab Holdings: lead

Study Sites (4)

Athena Specialty Group

Phoenix, Arizona, 85048, United States

Location

Revive Advanced Wound Care

Toms River, New Jersey, 08755, United States

Location

Houston Foot and Ankle Care

Houston, Texas, 77027, United States

Location

Houston Foot Dr

Houston, Texas, 77095, United States

Location

MeSH Terms

Conditions

Varicose Ulcer; Diabetic Foot; Pressure Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marshall Medley

  Sponsor GmbH

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 22, 2025
• Study Start: April 23, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)