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.
Parallel
PAW-Functionalized Carbopol® 940 Hydrogel
DeviceTopical application of a 1% w/v Carbopol® 940 hydrogel neutralized to pH 5.5, functionalized with Plasma-Activated Water (PAW) containing stabilized reactive oxygen and nitrogen species (RONS, including H₂O₂, O₃, NO₂-, NO₃-). A uniform layer (3-5 mm thick) is applied to the entire wound bed after saline cleaning, covered with a sterile secondary dressing. Frequency: 2-3 times per week depending on exudate level.
Standard Advanced Wound Care
Other interventionConventional advanced wound care following institutional protocol, including wound cleaning with saline, mechanical debridement, and application of standard dressings (e.g., alginate, foam, or silver dressings as clinically indicated). No PAW-hydrogel is used.
Rate of Wound Area Reduction
Change in wound surface area (mm²) per week, calculated from digital planimetry (ImageJ) of standardized photographs. Unit of measure: mm²/week.
Change in Bacterial Load
Reduction in semi-quantitative colony forming units (CFU) from wound bed swabs or tissue cultures. Unit of measure: CFU/g or semi-quantitative score.
Time to Complete Wound Closure
Number of days required for complete re-epithelialization (100% closure, no drainage). Unit of Measure: Days
Change in Pain Intensity
Patient-reported pain using a Visual Analog Scale (VAS, 0-10, where 0 = no pain and 10 = worst imaginable pain). Unit of Measure: Unit of Measure: 0-10 VAS score.
Change in Wound Tissue Quality
Assessment using the Bates-Jensen Wound Assessment Tool (or similar), evaluating granulation tissue, necrotic tissue, exudate, and surrounding skin. Unit of Measure: Total score.
Incidence of Treatment-Related Adverse Events
Number of participants with local adverse events (erythema, edema, pruritus, persistent pain) assessed by clinical examination and patient report. Unit of measure: Number of participants.
Click on the lead sponsor to view all of their trials.
Benjamín Gonzalo Rodríguez Méndez
Lead sponsor
National Institute of Nuclear Research - Mexico
Sponsor institution
Centro Medico Issemym
Collaborator
