Chronic non healing ulcer and bacteriophage therapy

Phase 2

Not yet recruiting

• Conditions: Local infection of the skin and subcutaneous tissue, unspecified,

• Registration Number: CTRI/2021/12/038527
• Lead Sponsor: Prof Gopal Nath

Brief Summary

This study is a single-centered, prospective, randomized, double-blind, parallel-group trial of a customized bacteriophage therapy versus the current standard of care dressings of chronic ulcers comparing the safety and efficacy of bacteriophage preparation. Bacteriophage colloquially referred to as ‘phages’ are bacterial viruses have emerged as a most promising alternative therapeutic agent due to its high target specificity, abundance, and lack of effective antibiotics against increasingly resistant pathogens. We have already demonstrated the successful cure of infection and complete healing of chronic wound in two prospective explorative studies by applying customized phages topically and results were encouraging, considering that all the medicated patients were suffering from wound infections that were untreatable using common antibiotics. Clinical trials are necessary for demonstrating that safety and efficacy data generated in a preclinical laboratory environment are translated reliably into clinical practice. This study is undertaken with an aim to treat individuals on a compassionate basis who will have exhausted all other treatment options which will be proved as a progressive approach in the regulated implementation of personalized bacteriophage therapeutics.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-11-18
• Study Start: 2021-12-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Males or females from 12 to 70 years, with or without type 1 or type 2 diabetes and a chronic, (present for at least 6 weeks) full-thickness ulcer not penetrating to the tendon, periosteum, or bone, and with a cross-sectional area between 25 and 2,500 mm2.
• Participants will be required to have either a palpable pedal pulse or an ankle-brachial pressure index (ABPI) of > 0.5. Participants with ulcer infection.
• Written informed consent.

Exclusion Criteria

Burn patients malignant ulcers ulcers due to systemic diseases except for diabetes mellitus ulcers due to arterial diseases Ulcers due to skin disorders Patients not giving consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of customized phage therapy as assessed by the % ulcer reduction by using Bates Jensen Criteria.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Until healthy granulation tissue formed or 12 weeks period or complete healing	After follow up

Trial Locations

Locations (1)

Sir Sunderlal Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

Sir Sunderlal Hospital

🇮🇳Varanasi, UTTAR PRADESH, India

Prof Gopal Nath

Principal investigator

9335058394

gopalnath@gmail.com