| NCT ID | NCT07541196 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Benjamín Gonzalo Rodríguez Méndez |
| Condition | Diabetic Foot Ulcer (DFU) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-04-20 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07541196 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Foot Ulcer (DFU). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07541196 currently recruiting?
Yes, NCT07541196 is actively recruiting participants. Contact the research team at regulo.lopez@inin.gob.mx for enrollment information.
Where is the NCT07541196 trial being conducted?
This trial is being conducted at Ocoyoacac, Mexico.
Who is sponsoring the NCT07541196 clinical trial?
NCT07541196 is sponsored by Benjamín Gonzalo Rodríguez Méndez. The trial plans to enroll 50 participants.