Clinical Trial

Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds

Recruiting
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Record status
This record was last updated December 31, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
Summary
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.
Trial Details
NCT Number NCT07312513
Lead Sponsor Lohmann & Rauscher
Collaborators: AXCELLANT
Conditions Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers, Postoperative Wounds Healing by Secondary Intention, Burns and Scalds, Epidermolysis Bullosa (EB), Traumatic Wounds +1 more
Enrollment 104 participants
Start Date 2025-05-09
Primary Completion 2026-02 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-12-31