Study to assess the Safety and Efficacy of Bacteriophage in the treatment of Diabetic foot infection.
- Conditions
- Non-pressure chronic ulcer of other part of foot,
- Registration Number
- CTRI/2023/11/059899
- Lead Sponsor
- TechnoPhage
- Brief Summary
This is a Phase 2b,double-blinded, randomised, placebo-controlled, multicentre study to determinethe safety and efficacy of TP-102, in patients with DFI.
A minimum of 80 (Eighty) patients (maximum of 96(Ninety-six)) with an infected DFU and with at least one target bacterialstrain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacterbaumannii) susceptible to TP-102, causing the infection as determined from theculture taken from the target ulcer at screening visit, will be included within10 days from screening.
Patients will be randomlyassigned in a 1:1 ratio to one of two treatments arms (TP-102 or Placebo) atDay 1. The wound SoC procedures are in accordance to each sites normal DFIroutine. Patients will be treated with a total of 12 treatments in 28 days (+3days) with at least one day of interval in between the days of treatment(consecutive days of treatment are not allowed) and a maximum of 3 (three) dayswithout treatment.
After completing treatment, patients will return forscheduled Follow-Up (FU) visits: 15 (FU1) and 60 (FU2) days after the last IPadministration.
Assessments for efficacy andsafety will include concomitant medications and AEs/AESI/SAE, physicalexamination, vital signs, clinical laboratory tests, target ulcer assessment(size, depth, volume, granulation, IWGDF-ISDA and PEDIS infectionclassification and DFUWI score), and wound biopsy (swab only as indicated) todetermine the presence and speciation of bacteria.
As part of the DSMB, adedicated, independent Adaptive Committee, exclusive of the SRC, will reviewsafety data and infectivity scoring and may recommend enrichment of the activearm where SAEs indicate that Placebo + SoC is significantly failing.
In this phase 2, PoC study, theprimary objectives are to evaluate the safety and efficacy of TP-102 asmeasured by TEAEs compared to Placebo and reduction of wound infection(IWGDF/ISDA and PEDIS infection classification and DFUWI score) and woundsurface by topically applied TP-102 in addition to SoC in DFIs. The reductionof wound surface will be evaluated as a prognostic indicator of complete woundhealing at 3 months after treatment with IP since wound healing depends onseveral factors that go beyond the infection reduction/ eradication.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 96
- Aged > 18 years old.
- 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.
- 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.
- 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.
- 1.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); 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.
- 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 Statistically significant changes in the percentage of patients in the respective IWGDF/IDSA classes , Treatment emergent Adverse events, | Statistically significant changes in the percentage of patients in the respective IWGDF/IDSA classes , | Percentage of patients that achieve at least 50% reduction in wound surface area by week 4 Percentage of patients that achieve at least 50% reduction in wound surface area by week 4 Treatment emergent Adverse events, | Statistically significant changes in the percentage of patients in the respective IWGDF/IDSA classes , | Percentage of patients that achieve at least 50% reduction in wound surface area by week 4 Treatment emergent Adverse events, Treatment emergent Adverse events, | Statistically significant changes in the percentage of patients in the respective IWGDF/IDSA classes , | 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 2. Percentage of patients with a value over clinical diagnostic cut-off for DFI for CRP/ESR/PCT/WBC count
Trial Locations
- Locations (8)
Aman Hospital & Research Centre
🇮🇳Vadodara, GUJARAT, India
Crescent Hospital & Heart Centre
🇮🇳Nagpur, MAHARASHTRA, India
GSVM Medical College
🇮🇳Nagar, UTTAR PRADESH, India
Jupiter Hospital & Research Centre
🇮🇳Vadodara, GUJARAT, India
M.V Hospital for Diabetes Pvt. Ltd
🇮🇳Chennai, TAMIL NADU, India
Parikh Multispeciality Health Care Private Limited
🇮🇳Vadodara, GUJARAT, India
Shree Siddhivinayak Maternity & Nursing Home
🇮🇳Nashik, MAHARASHTRA, India
Yalamanchi Hospitals & Research Centres Pvt. Ltd
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Aman Hospital & Research Centre🇮🇳Vadodara, GUJARAT, IndiaDr Aman Romesh KhannaPrincipal investigator9904402122amankhanna1974@gmail.com