PAW-Hydrogel for Chronic Wound Healing

Recruiting now · Not applicable

Conditions studied: Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU), Wound Dehiscence, Venous Leg Ulcer, Arterial Ulcer, Chronic Wound

In brief

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.

Key facts

Study ID

NCT07541196

Run by

Benjamín Gonzalo Rodríguez Méndez

People needed

50

Starts

2026-04-20

Expected to finish

2027-07-30

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Able and willing to provide written informed consent.

You may not qualify if…

• 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.
• Known autoimmune skin disease (e.g., pemphigus, epidermolysis bullosa).
• Active malignancy or undergoing chemotherapy/radiotherapy.
• Participation in another interventional clinical trial within 30 days prior to screening.

Where it is running

• Plasma Physics Laboratory, National Institute of Nuclear Research — Ocoyoacac, State of Mexico, Mexico (enrolling)

Full record on ClinicalTrials.gov

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