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PAW-Hydrogel for Chronic Wound Healing

NCT07541196 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer (DFU)
  • Pressure Ulcer (PU)
  • Wound Dehiscence
  • Venous Leg Ulcer
  • Arterial Ulcer
  • Chronic Wound

Interventions

DEVICE

PAW-Functionalized Carbopol® 940 Hydrogel

Topical application of a 1% w/v Carbopol® 940 hydrogel neutralized to pH 5.5, functionalized with Plasma-Activated Water (PAW) containing stabilized reactive oxygen and nitrogen species (RONS, including H₂O₂, O₃, NO₂-, NO₃-). A uniform layer (3-5 mm thick) is applied to the entire wound bed after saline cleaning, covered with a sterile secondary dressing. Frequency: 2-3 times per week depending on exudate level.

OTHER

Standard Advanced Wound Care

Conventional advanced wound care following institutional protocol, including wound cleaning with saline, mechanical debridement, and application of standard dressings (e.g., alginate, foam, or silver dressings as clinically indicated). No PAW-hydrogel is used.

Sponsors & Collaborators

  • Centro Medico Issemym

    collaborator OTHER

  • Benjamín Gonzalo Rodríguez Méndez

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2027-04-30
Completion
2027-07-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07541196 on ClinicalTrials.gov