A Phase 2b Clinical Study to Evaluate the Safety and Efficacy of Topical Administration ofBacteriophage Therapy TP-102 in Patients with Diabetic Foot Infection - TP-102_102

Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.0 sites80 target enrollmentSeptember 15, 2023

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.
Enrollment: 80
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 15, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.

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: 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.

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;, 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.