N/A
N=182
Less Infections for the Diabetic Foot
Diabetic Foot
Bottom Line
View on ClinicalTrials.gov: NCT03615807 ↗Enrolled (actual)
182
Serious AEs
6.9%
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants Experiencing Clinical Failure — 26; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Surgical debridement (if needed) (Procedure); Microbiological sampling (Diagnostic_test); Revascularisation (if needed). (Procedure); Off-loading (Device); Patient's education and instructions (Behavioral); Wound debridement (Procedure); Antibiotic duration (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Geneva
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Clinical Failure |
26; 30 | — |
| SECONDARY Number of Participants Experiencing Adverse Events Related to the Antibiotic Therapy |
31; 27 | — |
Summary
This is a randomized, unblinded, single-centre study. After eventual surgical debridement (not amputation), patients will be randomized to receive 1 of 2 targeted antibiotic regimens, in the ratio 1:1.
For diabetic toe osteomyelitis, the patients will be randomized between a 3 and a 6 week's arm, for soft tissue infections between 10 and 20 days. The final assessments used in the primary efficacy analysis will be obtained at the test-of-cure (TOC) visit approximately 60 days after treatment is stopped.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18
- Diabetes mellitus
- Diabetic Foot Infections
- Surgical intervention to remove all necrotic tissue or tenotomy.
- Osteomyelitis limited to bone contact or cortical lesions in X-ray.
Exclusion Criteria
- Implanted device.
- More than 96 hours of systemic antibiotic therapy prior to inclusion
- Amputation
- Destructive osteomyelitis
- Concomitant infections requiring more than 14 days of antibiotic therapy.
Data sourced from ClinicalTrials.gov (NCT03615807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.