PAW-Hydrogel for Chronic Wound Healing (NCT07541196) | Clinical Trial Compass
RecruitingNot Applicable
PAW-Hydrogel for Chronic Wound Healing
Mexico50 participantsStarted 2026-04-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Wound Area Reduction
Timeframe: From baseline to week 12, measured weekly.