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.
Adults ≥ 18 years of age.
Diagnosis of chronic wound (diabetic foot ulcer Wagner grade 1-2, pressure injury grade I-III, dehiscent surgical wound, venous or arterial ulcer) with duration > 3 months.
Wound surface area between 2 cm² and 20 cm².
For diabetic patients: HbA1c < 9% (stable metabolic control).
Clinical or radiological evidence of osteomyelitis (Wagner grade > 3).
Severe arterial insufficiency (ankle-brachial index < 0.5).
Use of systemic corticosteroids or immunosuppressants.
Pregnancy or lactation.
Benjamín Gonzalo Rodríguez Méndez
Lead sponsor
National Institute of Nuclear Research - Mexico
Sponsor institution
Centro Medico Issemym
Collaborator