Randomized Double-Blind Trial of Sodium Hypochlorite and Polyhexamethylene Biguanide for Diabetic Foot Ulcer Healing Efficacy

The primary objective of this randomized double-blind clinical trial is to evaluate the **time to healing** of **diabetic foot ulcers (DFU)**. This involves assessing the efficacy of local antimicrobial agents, specifically Hypochlorous Acid (HOCl) and Polyhexamethylene biguanide (PHMB), in achieving complete healing of DFU. The clinical relevance of this objective lies in its potential to improve treatment outcomes for patients with DFU, a common and serious complication of diabetes that can lead to significant morbidity.

Secondary objectives include:

• Evaluating differences in the proportion of DFU that heals within 12 weeks of treatment with HOCl and PHMB.
• Assessing changes in the size of the DFU's surface area over 24 weeks of treatment.
• Examining differences in the depth of the DFU over 24 weeks of treatment.
• Comparing the use of antibiotics over 24 weeks of treatment.
• Evaluating the impact on quality of life over 24 weeks of treatment using the EQ-5D questionnaire.

The clinical trial focuses on individuals diagnosed with **Diabetic Foot Ulcer**. The study population includes both male and female participants aged 18 years and older. Participants are required to have a foot ulcer present for at least 10 days with a surface area of 9 mm² or greater. The trial includes individuals with type 1 or type 2 diabetes, as well as diabetes resulting from pancreatitis. The sponsor has not provided the total number of participants involved in the study. The trial population was selected based on specific inclusion criteria, including the ability to provide written and verbal informed consent. The study considers a vulnerable population, but no additional lifestyle considerations such as diet or physical activity are specified. The sponsor has not disclosed further details regarding the general health status or habits of the participants.

The clinical trial is designed as a **randomized**, **double-blind**, controlled study aimed at evaluating the efficacy of local antimicrobial agents, specifically Hypochlorous Acid (HOCl) and Polyhexamethylene biguanide (PHMB), in the treatment of **diabetic foot ulcers**. The primary objective is to assess the time to complete healing of the ulcers over a 24-week treatment period. The trial will include adult participants aged 18 years or older with a diabetic foot ulcer present for at least 10 days and a surface area of at least 9 mm². Participants must have a diagnosis of type 1 or type 2 diabetes, or diabetes due to pancreatitis, and provide written and verbal informed consent prior to any trial-related activities.

The trial will commence with an inclusion (screening) visit to confirm eligibility based on the inclusion criteria. Following randomization, participants will be assigned to either the HOCl or PHMB treatment group. The study will involve regular follow-up visits to monitor the healing process, with assessments conducted at baseline, week 12, and week 24. The primary endpoint is the difference in time from baseline to healing, measured as a hazard ratio. Secondary endpoints include the proportion of healed ulcers at week 12, changes in ulcer surface area and depth, the mean number of days of antibiotic treatment, and changes in quality of life as measured by the EQ5-D questionnaire.

The expected duration of participant involvement is approximately 24 weeks, with the trial estimated to conclude by December 31, 2026. Conditions that may lead to early termination from the study include withdrawal of consent, adverse events, or any situation where continued participation is deemed not in the best interest of the participant. The trial is categorized as a phase III study, indicating its advanced stage in the clinical research process. The use of **sodium hypochlorite** as a cutaneous solution is central to the trial, with a maximum daily dose of 8 ml and a total dose not exceeding 192 ml over the treatment period.

The clinical trial involves the use of **sodium hypochlorite** as an experimental medication. Sodium hypochlorite is administered in the form of a cutaneous solution, specifically designed for **cutaneous use**. The maximum daily dose is 8 ml, with a total maximum dose of 192 ml over the course of the treatment. The treatment period is set for a maximum of 24 days. Sodium hypochlorite is of chemical origin and is not formulated for pediatric use. The solution is also referred to as Dakin's solution in the context of this study.

In addition to the experimental treatment, the trial includes a comparator treatment involving **hypochlorous acid** and **polyhexamethylene biguanide**. These agents are used to evaluate their efficacy in treating diabetic foot ulcers, with the primary objective being the time to complete healing. The trial is conducted in a randomized, double-blind manner to ensure unbiased results. Participant compliance with the dosing schedule is monitored throughout the study to maintain the integrity of the trial data.

The efficacy of the clinical trial will be assessed by evaluating the time to healing of diabetic foot ulcers (DFUs) using local antimicrobial agents, specifically Hypochlorous Acid (HOCl) and Polyhexamethylene biguanide (PHMB). The primary endpoint is the difference in time from baseline (randomization) to healing, measured as a hazard ratio over a 24-week treatment period. Secondary endpoints include the proportion of healed DFUs in the HOCl group versus the PHMB group at week 12, changes in the surface area and depth of the DFU from baseline to week 24, the mean number of days of antibiotic treatment, and changes in quality of life assessed using the EQ5-D questionnaire from baseline to week 24.