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

NCT07078968 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-07-22

No results posted yet for this study

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)

Interventions

DEVICE

Tri-Membrane Wrap™

Membrane Wrap™

DEVICE

Membrane Wrap™

Membrane Wrap™

DEVICE

Membrane Wrap-Hydro™

Membrane Wrap-Hydro™

OTHER

Standard of Care

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.

Sponsors & Collaborators

  • BioLab Holdings

    lead INDUSTRY

Principal Investigators

  • Marshall Medley · Sponsor GmbH

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-23
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07078968 on ClinicalTrials.gov