PAW-Hydrogel for Chronic Wound Healing (NCT07541196)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (8 items).
Location: Plasma Physics Laboratory, National Institute of Nuclear Research — Ocoyoacac, State of Mexico
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Plasma Physics Laboratory, National Institute of Nuclear Research — Ocoyoacac, State of Mexico
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.