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 present 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 (ClinicalTrials.gov identifier: NCT01137903) of patients with diabetes diagnosed with neuropathic foot ulcers complicated by osteomyelitis was carried out at the Diabetic Foot Unit at the Complutense University of Madrid. Patients were randomized into 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 (Q1 5, Q3 8) in the AG and 6 weeks (Q1 3, Q3 9) in the SG (p=0.72). Four patients from the AG worsened (16.6%) and underwent surgery. Three patients from the SG required reoperation. No difference was found between the two groups regarding minor amputations (p=0.336).
CONCLUSIONS Antibiotics 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.
- Received June 28, 2013.
- Accepted October 8, 2013.
- © 2013 by the American Diabetes Association.
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