Optimal Antibiotics for Operated Diabetic Foot Infections

Status Recruiting

Clinical Trial Summary

Diabetic foot problems, especially infections (DFI), require multiple resources including iterative surgeries and amputations, long-lasting antibiotic therapies, education, off-loading and eventually revascularization and appropriate foot-ware. Treatment is complicated, multidisciplinary, and marked with a high risk of recurrences. This is a retrospective and prospective cohort with side studies of pathologies and academic research questions that cannot be separated from each other. The investigators establish a retro-and prospective cohort of diabetic foot problems (ambulatory and hospitalized patients) and perform side studies to reduce the incidence of complications, and to reduce recurrences of DFI, cost and adverse events related to therapies. Cohort: Prospective and retrospective cohort of all diabetic foot problems with emphasis on surgical and infectious variables. Trial 1 (Randomized trial on residual infection after amputation): Determination of the level of amputation per MRI followed by a randomization concerning the duration of post-amputation systemic antibiotic therapy, if there is residual bone infection. Trial 2 (Randomized trial on infection without amputation): Determination of the duration of systemic antibiotic therapy in diabetic foot infections without Amputation of the infection.

Clinical Trial Description

Trial 1: At enrollment (Day 1), the investigator will prescribe empiric antibiotic treatment based on instructions provided in the protocol and determine the most appropriate route of administration (oral or IV) according to the patient's condition. Patients will be randomized in the ratio 1:1 between 1 versus 4 days for post-amputation soft tissue infections; and between 1 versus 3 weeks if there is microbiologically proven residual bone infection/contamination in the proximal stump samples of the residual bone. Trial 2: At enrollment (Day 1), the investigator will prescribe empiric antibiotic treatment based on instructions provided in the protocol and determine the most appropriate route of administration (oral or IV) according to the patient's condition. Patients will be randomized in the ratio 1:1 between 10 versus 20 days for post-debridement soft tissue infections; and between 3 versus 6 weeks for diabetic foot osteomyelitis post.-debridement (without amputation). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04081792
Study type	Interventional
Source	Balgrist University Hospital
Contact	Ilker Uckay, PD MD
Phone	+41443863705
Email	ilker.uckay@balgrist.ch
Status	Recruiting
Phase	N/A
Start date	September 4, 2019
Completion date	December 31, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.