Less Infections for the Diabetic Foot

June 2, 2020 updated by: Ilker Uckay, University Hospital, Geneva

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetic foot infections (DFI) are frequent and are associated with a high burden of morbidity, costs, recurrence risk or new episodes of infections. About two-third of recurrent DFI may reveal other microorganisms than in the previous period, suggesting new episodes of infection due to the underlying problem, and/or selection by prior antimicrobial therapy. Osteomyelitis in the diabetic toe is almost always established by contiguous spread of infection from a chronic ulcer. It occurs in up to 15% of patients with a diabetic foot ulcer and about 20% of all DFI (and over half of severe infections) involve bone at presentation. The severity of a diabetic foot infection is based on the local and systemic signs and symptoms of infection and has been categorically defined in the Infectious Disease Society of America guidelines for the "Diagnosis and Treatment of Diabetic Foot Infections" (IDSA guidelines).

Knowing the potential for poor outcomes, many clinicians have tended to treat DFIs with a long duration of antibiotic therapy, with many side effects, development and spreading of antibiotic resistance, and associated costs. Data from recent comparative trials has shown that 1-2 weeks is sufficient for most soft tissue infections, and 4 to 6 weeks appears adequate in those with (unresected) infected bone. Retrospective reviews over the past two decades have demonstrated that about two-thirds of selected patients with diabetic foot osteomyelitis can achieve remission with antibiotic therapy alone (i.e., without bone resection). One recent randomized trial found that treatment with only antibiotic therapy (given for 90 days) gave similar clinical outcomes to treatment with conservative surgery (removal only of the infected bone) along with just a short course of antibiotic therapy. Another randomized trial compared a 6-week against 12-week course of antibiotic therapy, without concomitant surgery, for diabetic foot osteomyelitis and also found similar outcomes.

Likewise, the optimal antibiotic duration for any skin and soft tissue infection is unknown. According to some databases of University of Geneva Hospitals, among 378 skin and soft tissue infections in 346, overall cure was achieved in 330 episodes (87%) after a median antibiotic administration of 15 days. In multivariate Cox regression analysis, duration of antibiotic therapy (HR 1.0, 95%CI 0.96-1.02) did not influence treatment failure among patients with positive MRSA carriage.

Our study intends to optimize the duration of antibiotic therapy in DFI; for skin and soft tissue infections as well as for diabetic toe osteomyelitis that is not amputated.

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18
  2. Diabetes mellitus
  3. Diabetic Foot Infections
  4. Surgical intervention to remove all necrotic tissue or tenotomy.
  5. Osteomyelitis limited to bone contact or cortical lesions in X-ray.

Exclusion Criteria:

  1. Implanted device.
  2. More than 96 hours of systemic antibiotic therapy prior to inclusion
  3. Amputation
  4. Destructive osteomyelitis
  5. Concomitant infections requiring more than 14 days of antibiotic therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short antibiotic arm
10 days for soft tissue infections 3 weeks for osteomyelitis
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
Active Comparator: Standard antibiotic arm
20 days for soft tissue infections 6 weeks for osteomyelitis
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Clinical Failure
Time Frame: 30-60 days
Visual and dichotomous evaluation regarding the numbers of clinical recurrence/failure
30-60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Adverse Events Related to the Antibiotic Therapy
Time Frame: 30-60 days
Adverse events related to the antibiotic therapy.
30-60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Ilker Uçkay, MD, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2017

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

July 30, 2018

First Posted (Actual)

August 6, 2018

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • n° 2016-01008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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