PAW-hydrogel to help chronic wounds like diabetic foot and leg ulcers heal faster

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, controlled, parallel-group trial comparing a PAW-functionalized Carbopol® 940 hydrogel applied 2–3 times weekly with standard advanced wound care in adults with chronic wounds that have failed to heal for more than three months. Participants are randomized 1:1 and treated at the Wound Clinic of Centro Médico ISSEMYM in collaboration with the Instituto Nacional de Investigaciones Nucleares, with PAW-hydrogel manufactured and quality-tested at ININ. Primary outcomes include wound area reduction by planimetry and changes in bacterial load, and safety will be monitored through local adverse events and pain reporting. The hydrogel is applied as a uniform 3–5 mm layer after cleansing, with regular follow-up visits for wound measurement and culture sampling.

Why it matters

Who can join: the full rules

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.

Where it's running

• Plasma Physics Laboratory, National Institute of Nuclear Research
  Ocoyoacac, State of Mexico, Mexico Recruiting

Study contacts

• Study coordinator: Régulo López-Callejas, PhD
• Email: regulo.lopez@inin.gob.mx
• Phone: +52 5553297200

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.