Comparison Between Two Durations of Antibiotherapy for Non-surgically-treated Diabetic Foot Osteomyelitis (CHRONOS-2)

• Status: Not yet recruiting
• Trial end date: 2026-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this clinical study is to compare the efficacy and tolerance of 3 versus 6 weeks of antibiotherapy in patients with diabetic foot osteomyelitis treated medically.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tourcoing Hospital
• Treatments: Anti-Bacterial Agents

Criteria

Inclusion Criteria:

• Patient aged ≥ 18 years

• Informed, written consent obtained from patient

• Patient having the rights to Frenc social insurrance

• For women of childbearing potential : any effective contraceptive is required

• Type 1 or 2 diabetic patients

• Diabetic patients treated non-surgically for an osteomyelitis of the forefoot affecting only one osteoarticular part/radial supported by adequate diagnostic imaging and bone biopsy performed through uninfected tissue.

• Two peripheral pulses or transcutaneous oxygen tension measurement (TcPO2 > 30mmHg) or ankle brachial index (ABI > 0.9)

• Patient without antibiotherapy during 2 weeks before D1.

• Glycated hemoglobin (HbA1C) < 12% ( measured maximum 2 months before D1)

• Use of offloading boot for diabetic foot is feasible

Exclusion Criteria:

• Bone fragmentation, articular destruction requiring bone resection or amputation.

• Gangrene

• More than one osteoarticular part/radial affected

• Contraindication for the use of offloading boot

• Contraindication for bone biopsy

• Contraindication for the full course of antibiotics (allergy or based on RCP)

• Other drug-drug interaction that contraindicated the full course of antibiotics

• Charcot foot

• Patient undergoing radiotherapy of chimiotherapy for malignant neoplasms

• Hepatic insufficiency (ASAT and/or ALAT > 3 times the normal level)

• Any disease or behaviour making impossible to follow the protocol or difficult to interpret the results

• Any disease or context making difficult to allow regular monitoring of the patient

• Participation in other interventional research during the study

• Curator or guardianship of patient placed under judicial protection

• Pregnancy or lactating women