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CTRI Number  CTRI/2025/02/080469 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Duration of Therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare 4 weeks duration versus 6 weeks duration of antibacterial medicines in the non-surgical treatment of bone infection of foot in people with diabetes. 
Scientific Title of Study   Single blind randomized clinical trial on 4 weeks versus 6 weeks antibiotic therapy in the management of non-surgically treated diabetic foot osteomyelitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amritava Ghosh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, G.E. Road, Tatibandh, Raipur, Chhattisgarh PIN- 492099

Raipur
CHHATTISGARH
492099
India 
Phone  07712577325  
Fax    
Email  amritavaghosh@aiimsraipur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Amritava Ghosh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, G.E. Road, Tatibandh, Raipur, Chhattisgarh PIN- 492099

Raipur
CHHATTISGARH
492099
India 
Phone  07712577325  
Fax    
Email  amritavaghosh@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query  
Name  Rupali Sharma 
Designation  Data Entry Operator 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, G.E. Road, Tatibandh, Raipur, Chhattisgarh PIN- 492099

Raipur
CHHATTISGARH
492099
India 
Phone  07712577325  
Fax    
Email  endocrinologyandmetabolism@aiimsraipur.edu.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Ansari Nagar, New Delhi, India PIN- 110029 
 
Primary Sponsor  
Name  Dr Amritava Ghosh 
Address  Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, G.E. Road, Tatibandh, Raipur, Chhattisgarh PIN- 492099 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Ashu Rastogi  Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh PIN- 160012 
Dr Pranab Kumar Sahana  Department of Endocrinology and Metabolism, Institute of Post Graduate Medical Education and Research, 244, A.J.C. Bose Road, Kolkata, West Bengal PIN- 700020 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amritava Ghosh  All India Institute of Medical Sciences, Raipur  Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, G.E. Road, Tatibandh, Raipur, Chhattisgarh PIN- 492099
Raipur
CHHATTISGARH 		 07712577325

amritavaghosh@aiimsraipur.edu.in 
Dr Pranab Kumar Sahana  Institute of Post Graduate Medical Education and Research, Kolkata  Department of Endocrinology and Metabolism, Institute of Post Graduate Medical Education and Research, 244, A.J.C. Bose Road, Kolkata, West Bengal PIN- 700020
Kolkata
WEST BENGAL 		 9231523624

pranabsahana@gmail.com 
Dr Ashu Rastogi  Postgraduate Institute of Medical Education and Research, Chandigarh  Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh PIN- 160012
Chandigarh
CHANDIGARH 		 9781001046

ashuendo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS Raipur  Approved 
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research  Approved 
IPGMEandR Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M868||Other osteomyelitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  4 weeks antibiotic therapy  Duration of antibiotic therapy will be 4 weeks. The choice of antibiotic will be at the discretion of the treating clinicians, guided by existing guidelines and taking into account allergies and comorbidities. Individuals will be treated first, with an empirical antibiotic therapy, to be modified if required, according to the results of microbiological culture, when the results become available.  
Comparator Agent  6 weeks antibiotic therapy  Duration of antibiotic therapy will be 6 weeks. The choice of antibiotic will be at the discretion of the treating clinicians, guided by existing guidelines and taking into account allergies and comorbidities. Individuals will be treated first, with an empirical antibiotic therapy, to be modified if required, according to the results of microbiological culture, when the results become available. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Presence of forefoot diabetic foot osteomyelitis.
2. Patient willing for a follow up of 6 months after completion of the antibiotic treatment.
3. Acceptance of local wound care, off-loading.
 
 
ExclusionCriteria 
Details  1. Patients who do not give consent to be included in the study.
2. Pregnant and lactating women.
3. Peripheral arterial disease.
4. Gangrene.
5. Indication for bone resection or amputation.
6. Any concomitant infection requiring systemic antibiotic therapy for more than 10 days.
7. Patient who has received more than 5 days of potentially effective systemic antibiotic therapy and the wound has been clinically improving.
8. Material-related infection.
9. Estimated Glomerular Filtration Rate i.e. eGFR less than 30.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Remission of diabetic foot osteomyelitis.  6 months after completion of the antibiotic treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events associated with antibiotic therapy.  4 weeks and 6 weeks 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is a randomized, single blind, parallel group, multi-center trial comparing the efficacy and safety of 4 weeks versus 6 weeks antibiotic therapy in 104 patients with non-surgically treated diabetic foot osteomyelitis that will be conducted in three centers in India. The primary outcome measure will be remission of diabetic foot osteomyelitis assessed at 6 months after completion of the antibiotic treatment. The secondary outcome will be adverse events associated with antibiotic therapy at 4 weeks and 6 weeks.

 
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