Actively Recruiting
PAW-Hydrogel for Chronic Wound Healing
Led by Benjamín Gonzalo Rodríguez Méndez · Updated on 2026-04-21
50
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
Sponsors
B
Benjamín Gonzalo Rodríguez Méndez
Lead Sponsor
C
Centro Medico Issemym
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PAW-Hydrogel for Chronic Wound Healing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Chronic wound diagnosis including diabetic foot ulcer (Wagner grade 1-2), pressure injury (grade I-III), dehiscent surgical wound, venous or arterial ulcer lasting more than 3 months
- Wound surface area between 2 cm8 and 20 cm8
- For diabetic patients, HbA1c less than 9% indicating stable metabolic control
- Able and willing to provide written informed consent
You will not qualify if you...
- Evidence of osteomyelitis clinically or by radiology (Wagner grade greater than 3)
- Severe arterial insufficiency with ankle-brachial index less than 0.5
- Current use of systemic corticosteroids or immunosuppressants
- Pregnancy or breastfeeding
- Known autoimmune skin diseases such as pemphigus or epidermolysis bullosa
- Active cancer or undergoing chemotherapy or radiotherapy
- Participation in another interventional clinical trial within 30 days before screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
Plasma Physics Laboratory, National Institute of Nuclear Research
Ocoyoacac, State of Mexico, Mexico, 52750
Actively Recruiting
Research Team
R
Régulo López-Callejas, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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