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PAW-Hydrogel for Chronic Wound Healing

RecruitingNAAges 18 Years - anyAllBenjamín Gonzalo Rodríguez Méndez
NCT07541196 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, debri

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📋 Eligibility rules (as published)
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.
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What it tests

  • PAW-Functionalized Carbopol® 940 Hydrogel
  • Standard Advanced Wound Care
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Where

1 site
Plasma Physics Laboratory, National Institute of Nuclear Research
Ocoyoacac, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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