ANTIBIOTIC-TREATMENT FOR UNCOMPLICATED NEUROPATHIC FOREFOOT ULCERS INDIABETES - A CONTROLLED TRIAL

To investigate the effect of oral antibiotics in purely neuropathic ul cers (Wagner grade 1-2, no osteomyelitis), a double blind placebo-cont rolled study was performed. Forty-four patients were enroled and subje cted to standard treatment with absolute pressure relief (half shoes), daily wound cleansing (topical disinfectant), sterile dressings (spec ialized nurse). Patients were randomized to an antibiotic (amoxicillin plus clavulanic acid), or placebo. The study was stopped when the ant ibiotic proved unsuitable according to swab result, or on clinical gro unds (no improvement within 6 days of recruitment). Main outcome measu re was the ulcer closing rate during 20 days, as assessed by standardi zed photographs. All ulcers except one were infected. Of the placebo g roup (n = 22), 2 patients had to be withdrawn within 6 days, versus 3 patients of the antibiotic-group (n = 22). In the placebo group, 10 ul cers were healed versus 6 ulcers in the antibiotic group (NS). Mean (9 5% CI) reduction in ulcer radius was 0.41 (0.21-0.61) mm day(-1) in th e placebo group versus 0.27 (0.15-0.39) mm day(-1) in the antibiotic g roup (NS). In conclusion, there is no benefit from antibiotic treatmen t with amoxicillin plus clavulanic acid as a supplement to standard th erapy in uncomplicated neuropathic foot ulcers, provided pressure reli ef is complete, and wound care is performed strictly supervised. Howev er, a Type-II statistical error cannot be excluded in this small study .