PAW-Hydrogel for Chronic Wound Healing

Официальное название

Efficacy and Safety of a Carbopol® 940 Hydrogel Functionalized With Plasma-Activated Water (PAW) in the Treatment of Chronic Wounds: A Randomized Controlled Trial

Обзор

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.

Подробное описание

This prospective, randomized, controlled, parallel-group trial will be conducted at the Wound Clinic and hospitalization services of the Centro Médico ISSEMYM Lic. Arturo Montiel Rojas (Metepec, State of Mexico, Mexico), in collaboration with the Instituto Nacional de Investigaciones Nucleares (ININ), which develops and characterizes the Plasma-Activated Water (PAW) and the functionalized hydrogel.

Adult patients (≥18 years) with chronic wounds of various etiologies - diabetic foot ulcers (Wagner grade 1-2), pressure injuries (grade I-III), dehiscent surgical wounds, venous ulcers, or arterial ulcers - that have failed to heal for more than 3 months and have a surface area between 2 cm² and 20 cm² will be screened. Eligible patients will be randomly allocated (1:1) to either the experimental group (PAW-hydrogel) or the active comparator group (standard advanced wound care). Randomization will be performed using a computer-generated sequence with opaque sealed envelopes.

The PAW-hydrogel intervention consists of a 1% w/v Carbopol® 940 hydrogel neutralized to pH 5.5 and functionalized with PAW generated by a dielectric barrier discharge (DBD) coaxial reactor. The hydrogel is produced under aseptic conditions at ININ, and each batch is tested for pH (5.5) and sterility before release. In the experimental arm, after standard wound cleaning with sterile saline, a uniform layer (3-5 mm thickness) of PAW-hydrogel is applied to cover the entire wound bed, followed by a sterile secondary occlusive dressing. The hydrogel is reapplied 2-3 times per week depending on exudate levels (more frequent for heavily exuding wounds). The control arm receives standard advanced wound care according to ISSEMYM protocols, which includes cleaning, mechanical debridement if needed, and application of conventional dressings (e.g., alginate, foam, or silver-based dressings as clinically indicated), without PAW-hydrogel.

The study is conducted in full compliance with the Declaration of Helsinki and Mexican health regulations (Ley General de Salud). The protocol, informed consent form, and all patient-facing materials have been approved by the Health Research and Research Ethics Committee of ISSEMYM (314/26). All participants provide written informed consent prior to any study procedure. Participants may withdraw at any time without affecting their medical care at ISSEMYM. Data confidentiality is ensured by coding patient identifiers.

Вмешательства

• Устройство 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.
• Другое 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.

Первичные конечные точки

• Rate of Wound Area Reduction [Срок оценки: From baseline to week 12, measured weekly.]
• Change in Bacterial Load [Срок оценки: Baseline, week 4, week 8, and week 12]

Вторичные конечные точки (5)

• Time to Complete Wound Closure [Срок оценки: Up to 12 weeks]
• Change in Pain Intensity [Срок оценки: Baseline, each treatment visit (up to 3 times per week), and at week 12.]
• Change in Wound Tissue Quality [Срок оценки: Baseline, week 2, week 4, week 8, and week 12.]
• Incidence of Treatment-Related Adverse Events [Срок оценки: From first application up to week 12.]
• Number of Dressing Changes Required [Срок оценки: From baseline to complete healing or up to 12 weeks.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Plasma Physics Laboratory, National Institute of Nuclear Research — Ocoyoacac

Публикации

• 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
• 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.
• 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
• Graves N, Phillips CJ, Harding K. A narrative review of the epidemiology and economics of chronic wounds. Br J Dermatol. 2022 Aug;187(2):141-148. doi: 10.1111/bjd.20692. Epub 2021 Sep 21. PMID 34549421
• 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

Идентификаторы

NCT: NCT07541196 · UEeIM: 314/26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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