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Less Infections for the Diabetic Foot

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ClinicalTrials.gov Identifier: NCT03615807
Recruitment Status : Completed
First Posted : August 6, 2018
Results First Posted : June 1, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Ilker Uckay, University Hospital, Geneva

Brief 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.


Condition or disease Intervention/treatment Phase
Diabetic Foot Procedure: Surgical debridement (if needed) Diagnostic Test: Microbiological sampling Procedure: Revascularisation (if needed). Device: Off-loading Behavioral: Patient's education and instructions Procedure: Wound debridement Drug: Antibiotic duration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two prospected-randomized protocols
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study Comparing Different Durations of Antibiotic Treatment for Diabetic Foot Infections
Actual Study Start Date : February 16, 2017
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of Participants Experiencing Clinical Failure [ Time Frame: 30-60 days ]
    Visual and dichotomous evaluation regarding the numbers of clinical recurrence/failure


Secondary Outcome Measures :
  1. Number of Participants Experiencing Adverse Events Related to the Antibiotic Therapy [ Time Frame: 30-60 days ]
    Adverse events related to the antibiotic therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615807


Locations
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Switzerland
Geneva University Hospitals
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Ilker Uçkay, MD University Hospital, Geneva
  Study Documents (Full-Text)

Documents provided by Ilker Uckay, University Hospital, Geneva:
Publications of Results:
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Responsible Party: Ilker Uckay, Prof. Dr. med Ilker Uçkay, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03615807    
Other Study ID Numbers: n° 2016-01008
First Posted: August 6, 2018    Key Record Dates
Results First Posted: June 1, 2020
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ilker Uckay, University Hospital, Geneva:
diabetic foot infections
antibiotic reduction
osteomyelitis
soft tissue infections
Additional relevant MeSH terms:
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Infection
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Anti-Bacterial Agents
Anti-Infective Agents