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CTRI Number  CTRI/2025/12/099222 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On: 16/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing two antibiotics (faropenem and amoxicillin-clavulanic acid) for treating foot infections in people with diabetes 
Scientific Title of Study   To compare the efficacy and safety of faropenem versus amoxicillin-clavulanic acid in patients of diabetic foot ulcers: a randomised, open label, controlled clinical study 
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 Vivek Sharma 
Designation  Professor 
Affiliation  Pt B. D Sharma PGIMS, Rohtak 
Address  3rd floor, Department of Pharmacology, PGIMS, Rohtak Haryana Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  919992198234  
Fax    
Email  Viveksharmapgimsrohtak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prince Hooda 
Designation  Junior Resident 
Affiliation  Pt B. D Sharma PGIMS, Rohtak 
Address  3rd floor, Department of Pharmacology, PGIMS, Rohtak Haryana Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  9050143543  
Fax    
Email  princehooda619@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prince Hooda 
Designation  Junior Resident 
Affiliation  Pt B. D Sharma PGIMS, Rohtak 
Address  3rd floor, Department of Pharmacology, PGIMS, Rohtak Haryana Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  9050143543  
Fax    
Email  princehooda619@gmail.com  
 
Source of Monetary or Material Support  
Pt. B.D.Sharma Post Graduate Institute of Medical Sciences Rohtak, PGIMS Rohtak, Daryao Nagar, Rohtak, Haryana, India 124001 
 
Primary Sponsor  
Name  Pt BD Sharma PGIMS Rohtak 
Address  Pt. B.D.Sharma Post Graduate Institute of Medical Sciences Rohtak, PGIMS Rohtak, Daryao Nagar, Rohtak, Haryana, India 124001 
Type of Sponsor  Government medical college 
 
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 
Dr Prince Hooda  Pt B.D Sharma PGIMS Rohtak  Room number 30, Ground floor, Department of Orthopaedics,Ch. Ranbir Singh OPD, Pt BD Sharma PGIMS Rohtak, Haryana 124001
Rohtak
HARYANA 
9050143543

Princehooda619@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E136||Other specified diabetes mellituswith other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Amoxicillin-Clavulanic Acid  Amoxicillin- Clavulanic Acid: 625 mg orally TDS and enrolled patients will be assessed at baseline and at the end of 2 weeks and on the 10th day post-therapy for Clinical Cure Rate, Microbiological assessment, Quality of life assessed using the Diabetic Foot Ulcer Scale-Short Form (DFS-SF) and Safety assessment in both treatment groups will be done throughout the study and specifically at 1 and 2 weeks after starting the drug treatment. 
Intervention  Faropenem  Faropenem 200 mg orally BD after meals and the enrolled patients will be assessed at baseline and at the end of 2 weeks and on the 10th day post-therapy for Clinical Cure Rate, Microbiological assessment, Quality of life assessed using the Diabetic Foot Ulcer Scale-Short Form (DFS-SF) and Safety assessment in both treatment groups will be done throughout the study and specifically at 1 and 2 weeks after starting the drug treatment.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients of either gender, more than 18 years of age.
2. Patient with a diagnosis of diabetic foot ulcers with Grade 1-2, as per The University
of Texas Wound Classification System
3. Patient willing to give written informed consent. 
 
ExclusionCriteria 
Details  1. Grade 3 ulcers as per the Texas
classification.

2. Patients with Known hypersensitivity to
study drugs.

3. Pregnancy and lactation.

4. Patients with severe renal impairment.

5. Concomitant use of other systemic
antibiotics.

6. Gangrene requiring immediate
amputation, necrotising fasciitis or
osteomyelitis.
7. Critical limb ischemia requiring
revascularisation.

8. Patients who refuse to give written
informed consent

9. Non Diabetic foot ulcer patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To assess the clinical efficacy of faropenem and amoxicillin-clavulanic acid in
diabetic foot ulcers by observing the resolution of signs and symptoms. 
1. Clinical Efficacy
assessment will be done
at baseline, 2 weeks and
day 10 post-therapy.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Microbiological assessment: Microbiological outcome will be assessed by collecting
a sample of the infection site for culture obtained from curettage of the wound base at
baseline and the end of 2 weeks.
2. Quality of life: Quality of life will be assessed using the Diabetic Foot Ulcer Scale-
Short Form (DFS-SF) (Annexure-VI) at baseline, at the end of 2 weeks and 10th day
post-therapy. 
1.Microbiological assessment will be checked at baseline and the end of 2 weeks.
2. Quality of life at baseline, at the end of 2 weeks and 10th day
post-therapy. 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   29/12/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Diabetic foot ulcers are a major complication of diabetes leading to significant morbidity mortality and healthcare costs. In India the prevalence is particularly high with diabetic foot ulcers being a leading cause of non traumatic limb amputations. Diabetic foot ulcers are often polymicrobial involving both Gram positive and Gram negative bacteria including multidrug resistant organisms. The increasing prevalence of antibiotic resistance complicates treatment and increases the risk of poor outcomes.

Effective outpatient management and step down therapy require potent oral antibiotics. While amoxicillin clavulanic acid is a well established option emerging resistance and limited efficacy against some pathogens necessitate evaluation of alternatives.

Faropenem a newer carbapenem and the only orally available antibiotic in its class offers broad spectrum coverage and may be effective against resistant organisms commonly found in diabetic foot ulcers. However there is limited clinical data directly comparing its efficacy and safety to established regimens such as amoxicillin clavulanic acid. There is a lack of robust comparative clinical studies evaluating the efficacy safety and quality of life outcomes of faropenem versus amoxicillin clavulanic acid in the Indian population with diabetic foot ulcers.

This study aims to address this gap and guide the development of evidence based guidelines aiding healthcare professionals in making informed decisions tailored to individual patient needs. Hence this study is ethically justified. All medications assessed in this study are approved by the Central Drugs Standard Control Organisation and are already marketed and available in the Indian market. The study will be conducted after obtaining approval from the Institutional Ethical Committee. Written informed consent will be obtained from all enrolled patients. Personal information will be kept strictly confidential. Data collected during the study will be used for academic purposes only.

 
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