Four-Week vs Six-Week Antibiotic Therapy in the Management of Nonsurgically Treated Diabetic Foot Osteomyelitis: Protocol for a Multicentric, Single-Blind Randomized Clinical Trial
Abstract
Background: Diabetic foot osteomyelitis (DFO) is a common complication and major cause of morbidity among people with diabetes mellitus. There has been growing acceptance of primarily nonsurgical (conservative) management of DFO based on antibiotics alone. However, the most appropriate duration of antibiotic therapy for DFO remains controversial. Current guidelines recommend antibiotic duration of up to 6 weeks for DFO. Although there has been growing interest in a shorter duration of antibiotic therapy, in absence of sufficient evidence, the extent to which the duration of antibiotic therapy can be shortened remains debatable. Determination of the optimal duration of antibiotic therapy would improve the outcomes of treatment of DFO while limiting side effects.
Objective: This study aims to determine the rates of remission (primary objective) and adverse events (secondary objective) associated with 4 vs 6 weeks of antibiotic therapy in nonsurgically treated DFO.
Methods: In this single-blind randomized clinical trial, eligible people with DFO who give consent will be randomized to 4 or 6 weeks of antibiotic therapy in a 1:1 ratio. Participants will be treated according to current guidelines. First, an empirical antibiotic therapy to be modified if required according to the results of bone culture will be administered. Additional supportive therapy (wound care, pressure off-loading, and professional care for control of glucose levels and other comorbidities) will be provided…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 52 participants or records.
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