RecruitingNot ApplicableNCT07541196

PAW-Hydrogel for Chronic Wound Healing

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

Sponsor

Benjamín Gonzalo Rodríguez Méndez

Enrollment

50 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer (DFU)Venous Leg Ulcer Wound Dehiscence Pressure Ulcer (PU)Arterial Ulcer

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria7

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.

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Interventions

DEVICEPAW-Functionalized Carbopol® 940 Hydrogel

Topical 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.

OTHERStandard Advanced Wound Care

Conventional 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.