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CTRI Number  CTRI/2021/12/038527 [Registered on: 08/12/2021] Trial Registered Prospectively
Last Modified On: 07/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Chronic non healing ulcer and bacteriophage therapy 
Scientific Title of Study   A randomized, placebo controlled, double blind clinical trial of therapeutic bacteriophage preparation in chronic antibiotic-resistant wound infections. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gopal Nath 
Designation  Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Department of Microbiology, Institute of Medical Sciences,Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9335058394  
Fax  91-542-367568  
Email  gopalnath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gopal Nath 
Designation  Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Department of Microbiology, Institute of Medical Sciences,Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9335058394  
Fax  91-542-367568  
Email  gopalnath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Subhash Lal Karn 
Designation  Ph.D. Scholar 
Affiliation  Institute of Medical Sciences,Banaras Hindu University 
Address  Department of Microbiology, Institute of Medical Sciences,Banaras Hindu University,Varanasi, Uttar Pradesh, India

Varanasi
UTTAR PRADESH
221005
India 
Phone  8604206579  
Fax    
Email  subas_karna@yahoo.com  
 
Source of Monetary or Material Support  
Professor Gopal Nath Department of Microbiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005, Uttar Pradesh, India 
 
Primary Sponsor  
Name  Prof Gopal Nath 
Address  Department of Microbiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005, Uttar Pradesh, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Gopal Nath  Sir Sunderlal Hospital  OPD no.114, Department of Surgery, Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH 		 9335058394
91-542-367568
gopalnath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Institute of Medical Sciences, Banaras Hindu University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Customized Bacteriophage preparation  Customized bacteriophage preparation with conc. of phages 9log 10/ml would be administered topically on every alternate day till wound surface become sterile. 
Comparator Agent  Sterile normal saline  Dressings with guaze piece containing normal saline in the volume of 500µL/cm2 on every alternate day till 90 days 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy of customized phage therapy as assessed by the % ulcer reduction by using Bates Jensen Criteria.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Until healthy granulation tissue formed or 12 weeks period or complete healing  After follow up 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/12/2021 
Date of Study Completion (India) 31/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Karn SL, Bhartiya SK, Pratap A, et al. A Randomized, Placebo-controlled, Double-blind Clinical Trial of Bacteriophage Cocktails in Chronic Wound Infections. The International Journal of Lower Extremity Wounds. 2024;0(0). doi:10.1177/15347346231226342  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 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. 
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