PAW-hydrogel to help chronic wounds like diabetic foot and leg ulcers heal faster

Efficacy and Safety of a Carbopol® 940 Hydrogel Functionalized With Plasma-Activated Water (PAW) in the Treatment of Chronic Wounds: A Randomized Controlled Trial

This trial will test whether a plasma-activated water–infused Carbopol® 940 hydrogel helps adults with long-standing wounds (diabetic foot, pressure, venous, arterial, or dehiscent ulcers) heal faster and have less bacteria compared with standard advanced wound care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Institute of Nuclear Research - Mexico (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Ocoyoacac, State of Mexico)
• Trial ID: NCT07541196 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, controlled, parallel-group trial comparing a PAW-functionalized Carbopol® 940 hydrogel applied 2–3 times weekly with standard advanced wound care in adults with chronic wounds that have failed to heal for more than three months. Participants are randomized 1:1 and treated at the Wound Clinic of Centro Médico ISSEMYM in collaboration with the Instituto Nacional de Investigaciones Nucleares, with PAW-hydrogel manufactured and quality-tested at ININ. Primary outcomes include wound area reduction by planimetry and changes in bacterial load, and safety will be monitored through local adverse events and pain reporting. The hydrogel is applied as a uniform 3–5 mm layer after cleansing, with regular follow-up visits for wound measurement and culture sampling.

Who should consider this trial

Good fit: Adults aged 18 or older with chronic wounds (>3 months) and wound surface area between 2 and 20 cm²—including Wagner grade 1–2 diabetic foot ulcers, pressure injuries grade I–III, dehiscent surgical wounds, and venous or arterial ulcers—with diabetic patients having HbA1c < 9% are ideal candidates.

Not a fit: Patients with clinical or radiologic osteomyelitis, severe arterial insufficiency (ABI < 0.5), active malignancy or immunosuppression, pregnancy, or wounds outside the size/duration criteria are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the PAW-hydrogel could speed wound closure, reduce bacterial burden, and lower the risk of infection or more invasive treatments for people with chronic wounds.

How similar studies have performed: Laboratory studies and small clinical reports of plasma-activated water and cold-plasma treatments show promising antimicrobial and healing effects, but PAW-functionalized hydrogels have limited clinical data and are relatively novel in practice.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Ocoyoacac, State of Mexico

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

Study contacts

• Study coordinator: Régulo López-Callejas, PhD

Conditions Diabetic Foot Ulcer; Pressure Ulcer; Wound Dehiscence; Venous Leg Ulcer; Arterial Ulcer; Chronic Wound; Plasma-Activated Water; PAW