An interventional study of PAW-Functionalized Carbopol® 940 Hydrogel and Standard Advanced Wound Care in Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU) and Wound Dehiscence, sponsored by Benjamín Gonzalo Rodríguez Méndez. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Benjamín Gonzalo Rodríguez Méndez · Not applicable, Interventional, and Treatment
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:
Participants will be randomly assigned to one of two groups:
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.
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Benjamín Gonzalo Rodríguez Méndez is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 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.
Time frame: Baseline, week 4, week 8, and week 12
Time to Complete Wound Closure
Number of days required for complete re-epithelialization (100% closure, no drainage). Unit of Measure: Days
Time frame: Up to 12 weeks
Change in Pain Intensity
Patient-reported pain using a Visual Analog Scale (VAS, 0-10, where 0 = no pain and 10 = worst imaginable pain). Unit of Measure: Unit of Measure: 0-10 VAS score.
Time frame: Baseline, each treatment visit (up to 3 times per week), and at week 12.
Change in Wound Tissue Quality
Assessment using the Bates-Jensen Wound Assessment Tool (or similar), evaluating granulation tissue, necrotic tissue, exudate, and surrounding skin. Unit of Measure: Total score.
Time frame: Baseline, week 2, week 4, week 8, and week 12.
Incidence of Treatment-Related Adverse Events
Number of participants with local adverse events (erythema, edema, pruritus, persistent pain) assessed by clinical examination and patient report. Unit of measure: Number of participants.
Time frame: From first application up to week 12.
Number of Dressing Changes Required
Total number of wound care sessions (dressing changes) needed per participant. Unit of measure: Count.
Time frame: From baseline to complete healing or up to 12 weeks.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Benjamín Gonzalo Rodríguez Méndez