Antibiotics versus conservative surgery for treating diabetic foot osteomyelitis: a randomized comparative trial.

OBJECTIVE: No prospective trials have been carried out comparing antibiotic treatment alone with primarily surgical treatment in patients with diabetes and foot osteomyelitis. The aim of the current study was to compare the outcomes of the treatment of diabetic foot osteomyelitis in patients treated exclusively with antibiotics versus patients who underwent conservative surgery, following up the patients for a period of 12 weeks after healing. RESEARCH DESIGN AND METHODS: Between 1 January 2010 and 31 December 2012, a prospective randomized comparative trial (clinical trial reg. no. NCT01137903, clinicaltrials.gov) of patients with diabetes who had received a diagnosis of neuropathic foot ulcers complicated by osteomyelitis was carried out at the Diabetic Foot Unit at the Complutense University of Madrid. Patients were randomized into the following two groups: the antibiotics group (AG) and the surgical group (SG). Antibiotics were given for a period of 90 days in the AG. Patients in the SG received conservative surgery with postoperative antibiotic treatment for 10 days.
RESULTS: Eighteen patients (75%) achieved primary healing in the AG, and 19 (86.3%) in the SG (P = 0.33). The median time to healing was 7 weeks (quartile [Q] 1 to Q5, Q3-Q8) in the AG and 6 weeks (Q1-Q3, Q3-Q9) in the SG (P = 0.72). The conditions of four patients from the AG worsened (16.6%), and they underwent surgery. Three patients from the SG required reoperation. No difference was found between the two groups regarding minor amputations (P = 0.336).
CONCLUSIONS: Antibiotic therapy and surgical treatment had similar outcomes in terms of healing rates, time to healing, and short-term complications in patients with neuropathic forefoot ulcers complicated by osteomyelitis without ischemia or necrotizing soft tissue infections.

RCT Entities:   Population Interventions Outcomes