Less Infections for the Diabetic Foot

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615807
• Other study ID #: n° 2016-01008
• Status: Completed
• Phase: N/A
• Start date: February 16, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: March 31, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Infection

Intervention

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

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Tone A, Nguyen S, Devemy F, Topolinski H, Valette M, Cazaubiel M, Fayard A, Beltrand É, Lemaire C, Senneville É. Six-week versus twelve-week antibiotic therapy for nonsurgically treated diabetic foot osteomyelitis: a multicenter open-label controlled rand — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Clinical Failure	Visual and dichotomous evaluation regarding the numbers of clinical recurrence/failure	30-60 days
Secondary	Number of Participants Experiencing Adverse Events Related to the Antibiotic Therapy	Adverse events related to the antibiotic therapy.	30-60 days