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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.

Single blind randomized clinical trial on 4 weeks versus 6 weeks antibiotic therapy in the management of non-surgically treated diabetic foot osteomyelitis - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080469
Enrollment
104
Registered
2025-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: M868- Other osteomyelitis

Interventions

Intervention1: 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

Sponsors

Dr Amritava Ghosh
Lead Sponsor
Dr Ashu Rastogi
Collaborator
Dr Pranab Kumar Sahana
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Remission of diabetic foot osteomyelitis.Timepoint: 6 months after completion of the antibiotic treatment.

Secondary

MeasureTime frame
Adverse events associated with antibiotic therapy.Timepoint: 4 weeks and 6 weeks

Countries

India

Contacts

Public ContactRupali Sharma

All India Institute of Medical Sciences, Raipur

amritavaghosh@aiimsraipur.edu.in07712577325

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 28, 2026