Comparison Between Two Durations of Antibiotherapy for Non-surgically-treated Diabetic Foot Osteo… (NCT05074147) | Clinical Trial Compass
WithdrawnPhase 3
Comparison Between Two Durations of Antibiotherapy for Non-surgically-treated Diabetic Foot Osteomyelitis (CHRONOS-2)
Stopped: logistical and financial problems
France0Started 2022-05-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 co…
What they're measuring
1
Percentage of treated patients achieving remission from the diabetic foot osteomyelitis at the end of follow-up