Bacteriophage therapy for diabetic foot infections

A Phase 2 CT to Evaluate the Safety and Efficacy of Topical Administration of Bacteriophage Therapy TP-102 in Patients With DFI

This study is testing a new bacteriophage treatment for people with infected diabetic foot ulcers to see if it can help clear the infection better than a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Technophage, SA (industry)
• Locations: 10 sites (Los Angeles, California and 9 other locations)
• Trial ID: NCT05948592 on ClinicalTrials.gov

What this trial studies

This Phase 2b clinical trial evaluates the safety and efficacy of TP-102, a novel bacteriophage cocktail targeting specific bacteria associated with diabetic foot infections. The study involves 80 patients with infected diabetic foot ulcers, who will be randomly assigned to receive either TP-102 or a placebo. Treatment consists of topical application of the bacteriophage solution three times a week over a 28-day period. Assessments will include monitoring for adverse events, local tolerability, and the effectiveness of the treatment in eradicating the targeted bacterial strains.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of diabetes and a specific type of infected foot ulcer meeting the study criteria.

Not a fit: Patients with diabetic foot infections not caused by the targeted bacterial strains or those with severe systemic infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from diabetic foot infections, potentially reducing the need for antibiotics and improving healing outcomes.

How similar studies have performed: While bacteriophage therapy is a novel approach, there have been preliminary studies suggesting potential success in similar applications, though this specific combination has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Aged ≥18 years old;
* Established diagnosis of Diabetes Mellitus (type I or II);
* Glycosylated hemoglobin (HbA1c) value \< 12.0%;
* Designated foot infection meets the following criteria:
* Present for at least 3 weeks;
* Below-ankle, full-thickness, cutaneous ulcer;
* Wound area (after debridement, if applicable) 1 to 20.0 cm2;
* PEDIS infection grade 2 or 3;
* PEDIS perfusion grade 1 or 2;
* PEDIS depth grade 1 or 2 (grade 3 at the discretion of the investigator e.g. if they have received appropriate surgical treatment to remove infected bones).
* Diabetic foot infection with at least one target bacterial strain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacter baumannii), susceptible to the TP-102 bacteriophage cocktail, as assessed from wound cultures;
* Patients of suitable physical and mental health as determined by the Investigator on the basis of medical history and general physical examination;
* Patients of childbearing potential must have a negative serum pregnancy test at screening;
* ICF signed voluntarily before any study-related procedure is performed, indicating that the patient understands the purpose of, and procedures required in the study and is willing to participate in the study.

Exclusion Criteria:

* Infected study ulcer less than 2 cm away from other ulcers, in the case of multiple ulcers;
* Patient receiving hyperbaric oxygen therapy (HBOT), negative pressure wound therapy (NPWT), bioengineering skin (BES) substitutes and/or growth factors;
* Patient which, in the opinion of the investigator, may not comply with study related procedures;
* Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator's discretion);
* Being pregnant or breastfeeding;
* Currently participating in another clinical trial or having participated in a previous clinical trial with receipt of an investigational product within 30 days of the first administration of IP;
* A condition that, in the opinion of the Investigator, could compromise the well-being of the patient or course of the study, or prevent the patient from meeting or performing any study requirements;
* Participants with hypersensitivity to any component of investigational products.

Where this trial is running

Los Angeles, California and 9 other locations

• Clemente Clinical Research — Los Angeles, California, United States (RECRUITING)
• Tranquil Clinical Research — Webster, Texas, United States (ACTIVE_NOT_RECRUITING)
• MV Hospital for Diabetes Pvt. Ltd — Chennai, India (RECRUITING)
• GSVM Medical College — Kanpur, India (RECRUITING)
• Crescent Hospital & Heart Centre — Nagpur, India (RECRUITING)
• Shree Siddhi Vinayak Hospital — Nashik, India (RECRUITING)
• Jupiter Hospital & Research Center — Vadodara, India (RECRUITING)
• Parikh Multispeciality Healthcare Pvt. Ltd — Vadodara, India (RECRUITING)
• Aman Hospital & Research Centre — Vadodara, India (RECRUITING)
• Yalamanchi Hospitals & Research Centers Pvt. Ltd — Vijayawada, India (RECRUITING)

Study contacts

• Principal investigator: Sachin Arsule — Shree Siddhi Vinayal Hospital
• Study coordinator: Sofia Corte Real, Deputy CEO

Conditions: Diabetic Foot Infection