Frontlight ResearchEarly access
WithdrawnPhase 3
Comparison Between Two Durations of Antibiotherapy for Non-surgically-treated Diabetic Foot Osteomyelitis (CHRONOS-2)
Key facts
- Who runs it
- Tourcoing Hospital
- Where
- France18 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Phase
- Phase 3
- Started
- 1 May 2022
- Expected to end
- Nov 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks
- Record updated
- 14 January 2026
- Why it stopped
- logistical and financial problems
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- 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
Who cannot take part
- Bone fragmentation, articular destruction requiring bone resection or amputation
- Other drug-drug interaction that contraindicated the full course of antibiotics
- Contraindication for the full course of antibiotics (allergy or based on RCP)
- 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
- Gangrene
- More than one osteoarticular part/radial affected
- Contraindication for the use of offloading boot
- Contraindication for bone biopsy
- Charcot foot
- Participation in other interventional research during the study
- Curator or guardianship of patient placed under judicial protection
- Pregnancy or lactating women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- 3 weeks antibiotherapyTreatment being tested
Patients are treated 3 weeks with appropriate antibiotics after antibiogram evaluation.
Treatment: Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks
- 6 weeks antibiotherapyTreatment being tested
Patients are treated 6 weeks with appropriate antibiotics after antibiogram evaluation.
Treatment: Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Three Weeks Versus Six Weeks Antibiotic Therapy for Nonsurgically Treated Diabetic Foot Osteomyelitis : a Multicenter, Randomized, Open-label and Controlled Study
- Record updated
- 14 January 2026