Overview

Less Infections for the Diabetic Foot

Status:
Completed

Trial end date:
2020-03-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University Hospital, Geneva

Treatments:

Anti-Bacterial Agents
Antibiotics, Antitubercular

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.