| 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
|
|
|
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
|
|
|
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. |