CTRI/2023/11/059899
Recruiting
Phase 2
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. - NI
TechnoPhage0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- TechnoPhage
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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