Condition: Diabetic Foot Ulcer (DFU) · Pressure Ulcer (PU) · Wound Dehiscence · Sponsor: Benjamín Gonzalo Rodríguez Méndez
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.
This description comes directly from the study's public registry record.
Régulo López-Callejas, PhD · +52 5553297200 · regulo.lopez@inin.gob.mx
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| Plasma Physics Laboratory, National Institute of Nuclear Research | Ocoyoacac, State of Mexico, Mexico | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07541196