Diabetic Foot Ulcer (DFU)NCT07541196
PAW-Hydrogel for Chronic Wound Healing
A study testing PAW-Functionalized Carbopol® 940 Hydrogel and Standard Advanced Wound Care in people with Diabetic Foot Ulcer (DFU) and Pressure Ulcer (PU), run by Benjamín Gonzalo Rodríguez Méndez at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU), Wound Dehiscence
- What is being tested?
- PAW-Functionalized Carbopol® 940 Hydrogel and Standard Advanced Wound Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 20 Apr 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Plasma Physics Laboratory, National Institute of Nuclear Research
Ocoyoacac, State of Mexico, 52750
Diego Medina-Castro, PhD, +52 5553297200 ext. 12230, diego.medina@inin.gob.mx
About this study
Official title: Efficacy and Safety of a Carbopol® 940 Hydrogel Functionalized With Plasma-Activated Water (PAW) in the Treatment of Chronic Wounds: A Randomized Controlled Trial
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)?
Read more
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.
Read the detailed description
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.
- Conditions
- Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU), Wound Dehiscence, Venous Leg Ulcer, Arterial Ulcer, Chronic Wound
- Being tested
- PAW-Functionalized Carbopol® 940 Hydrogel, Standard Advanced Wound Care
- Keywords
- Plasma-Activated Water, PAW, Hydrogel, Chronic Wounds, Diabetic Foot, Wound Healing, RONS
- Medical subject headings
- Diabetic Foot, Pressure Ulcer, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAW-Functionalized Carbopol® 940 HydrogelDevice
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.
Standard Advanced Wound CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Advanced Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, week 4, week 8, and week 12
Secondary outcomes (5)
Time to Complete Wound Closure
Number of days required for complete re-epithelialization (100% closure, no drainage). Unit of Measure: Days
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to complete healing or up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benjamín Gonzalo Rodríguez Méndez
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Medico Issemym
- Responsible party
- Sponsor-investigator, Benjamín Gonzalo Rodríguez Méndez, National Institute of Nuclear Research - Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541196
- Sponsor's protocol ID
- UEeIM: 314/26
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37395769Cuellar-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.
PubMed 41227178Graves 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.
PubMed 34549421McCarty 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.
PubMed 24688830
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Carbopol® 940 Hydrogel Functionalized With Plasma-Activated Water (PAW) in the Treatment of Chronic Wounds: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07541196
- Acronym / sponsor ID
- UEeIM: 314/26
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Benjamín Gonzalo Rodríguez MéndezUniversity, hospital or other
- Collaborators
- Centro Medico Issemym
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAW-Hydrogel | Experimental | Device: PAW-Functionalized Carbopol® 940 HydrogelParticipants 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. |
| Standard Advanced Wound Care | Active comparator | Other: Standard Advanced Wound CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAW-Functionalized Carbopol® 940 HydrogelTopical 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. | Device | PAW-Hydrogel |
| Standard Advanced Wound CareConventional 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. | Other | Standard Advanced Wound Care |
Primary outcome
Rate of Wound Area Reduction
Time frame: From baseline to week 12, measured weekly.
Change in wound surface area (mm²) per week, calculated from digital planimetry (ImageJ) of standardized photographs. Unit of measure: mm²/week.
Change in Bacterial Load
Time frame: Baseline, week 4, week 8, and week 12
Reduction in semi-quantitative colony forming units (CFU) from wound bed swabs or tissue cultures. Unit of measure: CFU/g or semi-quantitative score.
5 secondary outcomes
Time to Complete Wound Closure
Time frame: Up to 12 weeks
Change in Pain Intensity
Time frame: Baseline, each treatment visit (up to 3 times per week), and at week 12.
Change in Wound Tissue Quality
Time frame: Baseline, week 2, week 4, week 8, and week 12.
Incidence of Treatment-Related Adverse Events
Time frame: From first application up to week 12.
Number of Dressing Changes Required
Time frame: From baseline to complete healing or up to 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 37395769Armstrong 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.
- BackgroundCuellar-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: PubMed 41227178Shen 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.
- Background: PubMed 34549421Graves 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.
- Background: PubMed 24688830McCarty 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAW-Functionalized Carbopol® 940 Hydrogel and Standard Advanced Wound Care in people with Diabetic Foot Ulcer (DFU) and Pressure Ulcer (PU), run by Benjamín Gonzalo Rodríguez Méndez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Régulo López-Callejas, PhD (+52 5553297200 ext. 12239, regulo.lopez@inin.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Wound Area Reduction (time frame: From baseline to week 12, measured weekly.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07541196, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.