PAW-Hydrogel for Chronic Wound Healing

NCT07541196 | Recruiting

• 1 other identifier: UEeIM: 314/26
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Plasma-Activated Water; PAW; Hydrogel; Chronic Wounds; Diabetic Foot; Wound Healing; RONS

Outcome Measures

Primary Outcomes (2)

• Rate of Wound Area Reduction

  Change in wound surface area (mm²) per week, calculated from digital planimetry (ImageJ) of standardized photographs. Unit of measure: mm²/week.

  From baseline to week 12, measured weekly.

• Change in Bacterial Load

  Reduction in semi-quantitative colony forming units (CFU) from wound bed swabs or tissue cultures. Unit of measure: CFU/g or semi-quantitative score.

  Baseline, week 4, week 8, and week 12

Secondary Outcomes (5)

• Time to Complete Wound Closure

  Up to 12 weeks

• Change in Pain Intensity

  Baseline, each treatment visit (up to 3 times per week), and at week 12.

• Change in Wound Tissue Quality

  Baseline, week 2, week 4, week 8, and week 12.

• Incidence of Treatment-Related Adverse Events

  From first application up to week 12.

• Number of Dressing Changes Required

  From baseline to complete healing or up to 12 weeks.

Study Arms (2)

PAW-Hydrogel

EXPERIMENTAL

Participants randomized to this arm will receive topical application of the investigational product: a Carbopol® 940 hydrogel (1% w/v) neutralized to pH 5.5 and functionalized with Plasma-Activated Water (PAW) containing stabilized reactive oxygen and nitrogen species (RONS). At each wound care session (2-3 times per week), the wound bed is first cleaned with sterile saline. A uniform layer of PAW-hydrogel is then applied to cover the entire wound surface, followed by a sterile secondary occlusive dressing. The hydrogel remains in place until the next scheduled dressing change. Treatment continues for up to 12 weeks or until complete wound closure, whichever occurs first.

Device: PAW-Functionalized Carbopol® 940 Hydrogel

Standard Advanced Wound Care

ACTIVE COMPARATOR

Participants randomized to this arm will receive the institution's current standard advanced wound care protocol for chronic wounds, as routinely practiced at the Centro Médico ISSEMYM Wound Clinic. At each wound care session (2-3 times per week, consistent with the experimental arm), the wound bed is first cleaned with sterile saline, followed by mechanical debridement of devitalized tissue if clinically indicated by the treating clinician. Subsequently, a conventional advanced dressing is selected according to wound characteristics (exudate level, presence of infection, and tissue type) and applied to cover the wound bed, followed by a sterile secondary dressing. The dressing is changed at each scheduled visit. All participants also receive standard concomitant care as per institutional protocols.

Other: Standard Advanced Wound Care

Interventions

PAW-Functionalized Carbopol® 940 Hydrogel DEVICE

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.

PAW-Hydrogel

Standard Advanced Wound Care OTHER

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.

Standard Advanced Wound Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benjamín Gonzalo Rodríguez Méndez: lead
• Centro Medico Issemym: collaborator

Study Sites (1)

Plasma Physics Laboratory, National Institute of Nuclear Research

Ocoyoacac, State of Mexico, 52750, Mexico

RECRUITING

Related Publications (5)

• Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578.

  PMID: 37395769 BACKGROUND

• Cuellar-Gaona CG, et al. Potent antimicrobial activity of chitosan hydrogels: effects of plasma-activated water and carvacrol. Polym Eng Sci. 2026;66(3):1775-1785.

  BACKGROUND

• Shen AZ, Taha M, Ghannoum M, Tyring SK. Biofilms and Chronic Wounds: Pathogenesis and Treatment Options. J Clin Med. 2025 Nov 2;14(21):7784. doi: 10.3390/jcm14217784.

  PMID: 41227178 BACKGROUND

• Graves N, Phillips CJ, Harding K. A narrative review of the epidemiology and economics of chronic wounds. Br J Dermatol. 2022;187(2):141-148

  BACKGROUND

• McCarty SM, Percival SL. Proteases and Delayed Wound Healing. Adv Wound Care (New Rochelle). 2013 Oct;2(8):438-447. doi: 10.1089/wound.2012.0370.

  PMID: 24688830 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Pressure Ulcer; Varicose Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Central Study Contacts

Régulo López-Callejas, PhD

CONTACT

+52 5553297200; regulo.lopez@inin.gob.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)