CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 182 enrolled
Drug / intervention
Antibiotic duration +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03615807
NCT03615807N/ACompleted
CompareCT.gov

Randomized Study Comparing Different Durations of Antibiotic Treatment for Diabetic Foot Infections

University Hospital, Geneva·interventional·Posted Aug 6, 2018·Updated Jun 9, 2020

In Brief

A clinical study evaluating Surgical debridement (if needed), Microbiological sampling, and 5 other interventions for Diabetic Foot. Completed, enrolled 182 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot
CountriesSwitzerland
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 6, 2018
Enrollment StartFeb 16, 2017
Primary CompletionFeb 29, 2020
Study CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.9 years ago

Interventions

Surgical debridement (if needed)procedure

Surgical debridement

Microbiological samplingother

Microbiological sampling

Revascularisation (if needed).procedure

Revascularisation (if needed).

Off-loadingdevice

Off-loading by Special shoes

Patient's education and instructionsbehavioral

Patient's education and instructions by specialized nurses

Wound debridementprocedure

Regular wound debridement by specialized nurses

Antibiotic durationdrug

Systemic antibiotic duration according to the study arms