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A Phase 2b Clinical Study to Evaluate the Safety and Efficacy of Topical Administration of Bacteriophage Therapy TP-102 in Patients with Diabetic Foot Infection
EU CTIS ID: 2023-507716-13-00
What this study is testing
Safety: 1. Safety and tolerability of TP-102 as compared to Placebo, in addition to Standard of Care (SoC); Efficacy: 2. Clinical improvement in diabetic foot infection classification (IWGDF/IDSA) of TP-102 as compared to Placebo, in addition to SoC; 3. Effects of TP-102 on wound healing as compared to Placebo, in addition to SoC.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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: a. Present for at least 3 weeks; b. Below-ankle, full-thickness, cutaneous ulcer; c. Wound area (after debridement, if applicable) below or equal to 20.0 cm2; d. IWGDF/IDSA classification of Mild to Moderate / PEDIS infection grade 2 or 3; e. PEDIS perfusion grade 1 or 2; f. 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 with suitable physical and mental health as determined by the Investigator based on medical history and general physical examination;
You likely can't join if
- 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;
- 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;
See the full eligibility 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: a. Present for at least 3 weeks; b. Below-ankle, full-thickness, cutaneous ulcer; c. Wound area (after debridement, if applicable) below or equal to 20.0 cm2; d. IWGDF/IDSA classification of Mild to Moderate / PEDIS infection grade 2 or 3; e. PEDIS perfusion grade 1 or 2; f. 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 with suitable physical and mental health as determined by the Investigator based on medical history and general physical examination;
- A woman of childbearing potential (WOCBP) (including egg donors) must have a negative Serum Pregnancy Test at screening
- WOCBP must agree to use one of the following forms of birth control whilst receiving study medications and for 4 (four) weeks after stopping study medications: a. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: a. Oral b. Intravaginal c. Transdermal b. progestogen-only hormonal contraception associated with inhibition of ovulation: a. Oral b. Injectable c. implantable c. Intrauterine device (IUD) d. Intrauterine hormone-releasing system (IUS) e. Bilateral tubal occlusion f. Vasectomised partner g. Sexual abstinence
- 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.
- 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;
- 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;
- Patient which, in the opinion of the investigator, may not comply with study related procedures;
- Participants with hypersensitivity to any component of investigational products.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.