title: Six-week versus twelve-week antibiotic therapy for nonsurgically treated diabetic foot osteomyelitis: a multicenter open-label controlled randomized study.
abstract: OBJECTIVE
  Little is known about the optimal duration of antibiotic therapy for diabetic foot osteomyelitis (DFO). This study sought to compare the effectiveness of 6 versus 12 weeks of antibiotic therapy in patients with DFO treated nonsurgically (i.e., antibiotics alone).
  
  
  METHODS
  This was a prospective randomized trial comparing 6- versus 12-week duration of antibiotic treatment. Remission of osteomyelitis during the monitoring period was defined as complete and persistent (>4 weeks) healing of the wound (if present initially), absence of recurrent infection at the initial site or that of adjacent rays, and no need for surgical bone resection or amputation at the end of a follow-up period of at least 12 months after completion of antibiotic treatment.
  
  
  RESULTS
  Forty patients followed at five French general hospitals were randomized between January 2007 and January 2009, with 20 treated for 6 weeks and 20 treated for 12 weeks with antibiotics. The two groups were comparable for all variables recorded at inclusion in the study. Remission was obtained in 26 (65%) patients, with no significant differences between patients treated for 6 versus 12 weeks (12/20 vs. 14/20, respectively; P = 0.50). We did not identify any significant parameters associated with patient outcome. Fewer patients treated for 6 weeks experienced gastrointestinal adverse events related to antimicrobial therapy compared with patients treated for 12 weeks (respectively, 15 vs. 45%; P = 0.04).
  
  
  CONCLUSIONS
  The present multicenter prospective randomized study provides data suggesting that 6-week duration of antibiotic therapy may be sufficient in patients with DFO for whom nonsurgical treatment is considered.
authors.affiliation: Infectious Diseases Department, Gustave Dron Hospital, Tourcoing, France.
authors.forename: Alina
authors.initials: A
authors.lastname: Tone
authors.affiliation: Infectious Diseases Department, Gustave Dron Hospital, Tourcoing, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Nguyen
authors.affiliation: Diabetology Unit, General Hospital of Lens, Lens, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Devemy
authors.affiliation: Diabetology Unit, General Hospital of Béthune, Béthune, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Topolinski
authors.affiliation: Infectious Diseases Department, Gustave Dron Hospital, Tourcoing, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Valette
authors.affiliation: Diabetology Unit, Gustave Dron Hospital, Tourcoing, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Cazaubiel
authors.affiliation: Diabetology Unit, General Hospital of Arras, Arras, France.
authors.forename: Armelle
authors.initials: A
authors.lastname: Fayard
authors.affiliation: Orthopedic Surgery Unit, Gustave Dron Hospital, Tourcoing, France.
authors.forename: Éric
authors.initials: É
authors.lastname: Beltrand
authors.affiliation: Diabetology Unit, General Hospital of Béthune, Béthune, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Lemaire
authors.affiliation: Infectious Diseases Department, Gustave Dron Hospital, Tourcoing, France esenneville@ch-tourcoing.fr.
authors.forename: Éric
authors.initials: É
authors.lastname: Senneville
mesh_terms: D000671:Amputation, Surgical / Q000706:statistics & numerical data; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D017719:Diabetic Foot / Q000150:complications / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010019:Osteomyelitis / Q000150:complications / Q000188:drug therapy*; D011446:Prospective Studies; D012293:Rifampin / Q000008:administration & dosage*; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D012293:Rifampin