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

Status: Recruiting

Location: See location...

Intervention Type: Other, Device

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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.

Locations

Other Locations

Mexico

Plasma Physics Laboratory, National Institute of Nuclear Research

RECRUITING

Ocoyoacac

Contact Information

Primary

Régulo López-Callejas, PhD

regulo.lopez@inin.gob.mx

+52 5553297200

Time Frame

Start Date: 2026-04-20

Estimated Completion Date: 2027-07-30

Participants

Target number of participants: 50

Treatments

Experimental: PAW-Hydrogel

Participants randomized to this arm will receive topical application of the investigational product: a Carbopol® 940 hydrogel (1% w/v) neutralized to pH 5.5 and functionalized with Plasma-Activated Water (PAW) containing stabilized reactive oxygen and nitrogen species (RONS). At each wound care session (2-3 times per week), the wound bed is first cleaned with sterile saline. A uniform layer of PAW-hydrogel is then applied to cover the entire wound surface, followed by a sterile secondary occlusive dressing. The hydrogel remains in place until the next scheduled dressing change. Treatment continues for up to 12 weeks or until complete wound closure, whichever occurs first.

Active_comparator: Standard Advanced Wound Care

Participants randomized to this arm will receive the institution's current standard advanced wound care protocol for chronic wounds, as routinely practiced at the Centro Médico ISSEMYM Wound Clinic. At each wound care session (2-3 times per week, consistent with the experimental arm), the wound bed is first cleaned with sterile saline, followed by mechanical debridement of devitalized tissue if clinically indicated by the treating clinician. Subsequently, a conventional advanced dressing is selected according to wound characteristics (exudate level, presence of infection, and tissue type) and applied to cover the wound bed, followed by a sterile secondary dressing. The dressing is changed at each scheduled visit. All participants also receive standard concomitant care as per institutional protocols.

Related Therapeutic Areas

Varicose Veins

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