Clinical Trial

PAW-Hydrogel for Chronic Wound Healing

Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers, pressure injuries, dehiscent wounds, arterial and venous ulcers). The main questions it aims to answer are: * Does PAW-hydrogel accelerate wound closure (reduction in surface area) compared to standard advanced wound care? * Does PAW-hydrogel reduce bacterial load in the wound bed? * Is PAW-hydrogel safe and well-tolerated (local adverse events, pain)? Participants will be randomly assigned to one of two groups: * Experimental group: Topical application of PAW-hydrogel (Carbopol® 940 neutralized to pH 5.5, loaded with reactive oxygen and nitrogen species from plasma activation) 2-3 times per week. * Control group: Standard advanced wound care (cleaning, debridement, conventional dressings). Wound area (planimetry), bacterial load (semi-quantitative cultures), pain (Visual Analog Scale), tissue quality (Bates-Jensen scale), and adverse events will be assessed over a 12-week follow-up period.
Trial Details
NCT Number NCT07541196
Lead Sponsor Benjamín Gonzalo Rodríguez Méndez
Collaborators: Centro Medico Issemym
Conditions Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU), Wound Dehiscence, Venous Leg Ulcer, Arterial Ulcer, Chronic Wound
Enrollment 50 participants
Start Date 2026-04-20
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-21