Study to assess the Safety and Efficacy of Bacteriophage in the treatment of Diabetic foot infection.

Phase 2

Conditions: Health Condition 1: L975- Non-pressure chronic ulcer of other part of foot

Registration Number: CTRI/2023/11/059899

Lead Sponsor: TechnoPhage

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Aged > 18 years old.

2. Established diagnosis of Diabetes mellitus (Type I or Type II)

3. Glycosylated hemoglobin (HbA1C) value < 12.0 %

4. 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)

5. 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-

6. Patients with suitable physical and mental health as determined by the Investigator based on medical history and general physical examination.

7. Patients with childbearing potential must have a negative Serum Pregnancy Test at screening-

8. Female and male participants of reproductive potential who are participating in sexual activity that could lead to pregnancy 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. Male or female condoms

b. Diaphragm or cervical cap with spermicide (if available)

c. Intrauterine device (IUD)

d. Oral contraceptive or Depo-Provera

Note A: Female participants who are not of reproductive potential are eligible without the use of contraceptives. Participant reported history is acceptable documentation of menopause (i.e., at least one-year amenorrheic), hysterectomy or bilateral oophorectomy or bilateral tubal ligation; these participants are all considered not of reproductive potential.

Note B: Male participants who are not of reproductive potential (i.e., documented azoospermia) or whose female partner/s are not of reproductive potential (as defined above) are eligible without requiring the use of contraceptives.

9. ICF signed voluntarily before any study-related procedure is performed, indicating that the patient understands the purpose and procedures required in the study and is willing to participate.

Exclusion Criteria

1.Infected study ulcer less than 2 cm away from other ulcers, in the case of multiple ulcers.

2. Patient receiving Hyperbaric Oxygen Therapy (HBOT), Negative Pressure Wound Therapy (NPWT), Bioengineering Skin (BES) substitutes and/or growth factors.

3. Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator’s discretion);

4. Being pregnant or breastfeeding;

5. 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;

6. 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;

7. Patient which, in the opinion of the investigator, may not comply with study related procedures;

8. Participants with hypersensitivity to any component of investigational products

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment emergent Adverse events, <br/ ><br>Statistically significant changes in the percentage of patients in the respective IWGDF/IDSA classes , <br/ ><br>Percentage of patients that achieve at least 50% reduction in wound surface area by week 4Timepoint: Treatment emergent Adverse events, <br/ ><br>Statistically significant changes in the percentage of patients in the respective IWGDF/IDSA classes , <br/ ><br>Percentage of patients that achieve at least 50% reduction in wound surface area by week 4

Secondary Outcome Measures

Name	Time	Method
1.Change in mean CRP/ESR/PCT/WBC count value <br/ ><br>2. Percentage of patients with a value over clinical diagnostic cut-off for DFI for CRP/ESR/PCT/WBC count <br/ ><br>3. Percentage eradication of TP-102 susceptible strains for TP-102 versus Placebo <br/ ><br>4. Percentage of patients with target strain not susceptible to TP-102 for TP-102 versus Placebo <br/ ><br>5. Changes in wound size, depth, granulation, complete or partial closure <br/ ><br>6. Percentage of patients that achieve wound healing complete wound closure <br/ ><br>Timepoint: Day 1 (Baseline) to EOT <br/ ><br> <br/ ><br>Day 1 (Baseline) to EOT <br/ ><br> <br/ ><br>At End of Treatment <br/ ><br>At End of Treatment <br/ ><br>Day 3, 8, 15, EOT and EOS <br/ ><br>Day 1 (Baseline) to FUP2 <br/ ><br>