PAW-Hydrogel for Chronic Wound Healing

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

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.

Conditions7

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