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Less Infections for the Diabetic Foot

NCT03615807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2020-06-09

Study results available
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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.

Conditions

  • Diabetic Foot

Interventions

PROCEDURE

Surgical debridement (if needed)

Surgical debridement

DIAGNOSTIC_TEST

Microbiological sampling

Microbiological sampling

PROCEDURE

Revascularisation (if needed).

Revascularisation (if needed).

DEVICE

Off-loading

Off-loading by Special shoes

BEHAVIORAL

Patient's education and instructions

Patient's education and instructions by specialized nurses

PROCEDURE

Wound debridement

Regular wound debridement by specialized nurses

DRUG

Antibiotic duration

Systemic antibiotic duration according to the study arms

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Ilker Uçkay, MD · University Hospital, Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-16
Primary Completion
2020-02-29
Completion
2020-03-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03615807 on ClinicalTrials.gov