FindTrial
Sign In

A study comparing two antibiotics (faropenem and amoxicillin-clavulanic acid) for treating foot infections in people with diabetes

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099222
Enrollment
84
Registered
2025-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E136- Other specified diabetes mellituswith other specified complications

Interventions

Intervention1: 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 Rat

Sponsors

Pt BD Sharma PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1. To assess the clinical efficacy of faropenem and amoxicillin-clavulanic acid in diabetic foot ulcers by observing the resolution of signs and symptoms.Timepoint: 1. Clinical Efficacy assessment will be done at baseline, 2 weeks and day 10 post-therapy.—

Secondary

MeasureTime frame
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.Timepoint: 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.—

Countries

India

Contacts

Public ContactDr Prince Hooda

Pt B. D Sharma PGIMS, Rohtak

princehooda619@gmail.com9050143543

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026