Efficacy of Phage Therapy Combined with Standard Treatment Versus Standard Treatment Plus Placebo in Staphylococcus aureus-Infected Diabetic Foot Ulcers

The primary objective of this study is to evaluate the **efficacy** of standard treatment combined with phage therapy compared to standard treatment plus placebo in the management of diabetic foot ulcers infected by **Staphylococcus aureus**. This is clinically relevant as diabetic foot ulcers are a common complication in patients with diabetes, often leading to severe infections and potential amputations. The introduction of phage therapy could offer a novel approach to enhance treatment outcomes and reduce the burden of antibiotic resistance.

The clinical trial focuses on individuals diagnosed with **diabetic foot**. The study population includes both male and female participants, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected without specific mention of lifestyle considerations such as diet, physical activity, or habits. The sponsor has not disclosed detailed inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the **efficacy** of standard treatment combined with phage therapy compared to standard treatment plus placebo for **diabetic foot** ulcers infected by **Staphylococcus aureus**. This study will employ a randomized, double-blind, controlled trial design to ensure the reliability and validity of the results. The trial is expected to commence recruitment on January 1, 2025, and conclude by August 31, 2026, providing a comprehensive evaluation period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful inclusion, participants will be randomly assigned to either the treatment or placebo group. Throughout the trial, follow-up visits will be scheduled at regular intervals to monitor the participants' progress, adherence to the treatment protocol, and any adverse events. The end-of-study visit will serve to collect final data and ensure the well-being of the participants.

The expected duration of participant involvement will span the entire trial period, from the initial screening to the end-of-study visit. However, certain conditions may necessitate early termination from the study, such as the occurrence of serious adverse events, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial will adhere to ethical standards and regulatory requirements to safeguard participant safety and data integrity.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a paediatric formulation or if it has orphan drug status. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available in the provided data.

The clinical trial is scheduled to commence recruitment on January 1, 2025, with an estimated completion date of August 31, 2026. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Efficacy assessments will be conducted throughout the trial period, although specific parameters or endpoints for evaluating efficacy, such as symptom improvement scores or biomarker levels, are not detailed in the available data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters, as well as any tools or instruments involved, are not specified. The trial's primary and secondary endpoints remain unspecified, and no information is provided regarding the medical condition being studied or the main objective of the trial. Consequently, the description of efficacy assessment is limited to the timeline and phase of the trial.