title: Targeted treatment of invasive fungal infections accelerates healing of foot wounds in patients with Type 2 diabetes.
abstract: OBJECTIVE
  To test the hypothesis that fluconazole plus standard care is superior to the standard care for diabetic foot wounds infected with deep-seated fungal infections.
  
  
  METHODS
  We carried out a randomized, controlled, open-label, parallel-arm study in 75 patients with both fungal and bacterial infections in deep tissues of diabetic foot wounds. Thirty-seven patients (control group) were given standard care (surgical debridement + culture-specific antibiotics + offloading + glycaemic control) and 38 patients (treatment group) were given fluconazole 150 mg daily plus standard care. Wound surface area was measured every 2 weeks until the endpoints (complete epithelialization or skin grafting) were met.
  
  
  RESULTS
  By week 4, the mean wound surface area reduced to 27.3 from 111.5 cm(2) in the treatment group, as opposed to 67.1 from 87.3 cm(2) in the control group. Subsequently, the mean wound surface areas were remarkably smaller in the treatment group compared with the control group, and statistically significant differences (P ≤ 0.05) in mean wound surface area were observed between the treatment group and the control group at week 6. However, no statistically significant (P ≤ 0.47) difference in complete healing was observed between the treatment group and the control group, 20 vs. 24. The mean wound healing time for the treatment group was 7.3 weeks, whereas for the control group it was 11.3 weeks (P ≤ 0.022). Similarly, the probability of wound healing in the treatment group was 50 vs. 20% in the control group at week 10.
  
  
  CONCLUSIONS
  Fluconazole plus standard care was superior to standard care alone in accelerating wound reduction among patients with diabetes with deep-seated fungal infections in diabetic foot wounds. Those in the treatment group who did heal, healed more quickly (P ≤ 0.022), but overall healing was not different.
authors.affiliation: Department of Endocrinology, Diabetes and Podiatry, School of Medicine, Amrita Institute of Medical Sciences and Research Center, Kerala, India. gopic@aims.amrita.edu
authors.forename: G
authors.initials: G
authors.lastname: Chellan
authors.forename: K
authors.initials: K
authors.lastname: Neethu
authors.forename: A K
authors.initials: AK
authors.lastname: Varma
authors.forename: T S
authors.initials: TS
authors.lastname: Mangalanandan
authors.forename: S
authors.initials: S
authors.lastname: Shashikala
authors.forename: K R
authors.initials: KR
authors.lastname: Dinesh
authors.forename: K R
authors.initials: KR
authors.lastname: Sundaram
authors.forename: N
authors.initials: N
authors.lastname: Varma
authors.forename: R V
authors.initials: RV
authors.lastname: Jayakumar
authors.forename: A
authors.initials: A
authors.lastname: Bal
authors.forename: H
authors.initials: H
authors.lastname: Kumar
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000935:Antifungal Agents / Q000494:pharmacology* / Q000627:therapeutic use; D001424:Bacterial Infections / Q000188:drug therapy / Q000453:epidemiology; D001786:Blood Glucose / Q000378:metabolism; D016022:Case-Control Studies; D015897:Comorbidity; D003646:Debridement; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D017719:Diabetic Foot / Q000453:epidemiology / Q000382:microbiology* / Q000628:therapy*; D005260:Female; D015725:Fluconazole / Q000494:pharmacology / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000188:drug therapy* / Q000453:epidemiology; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects* / Q000502:physiology
chemical_list: D000900:Anti-Bacterial Agents; D000935:Antifungal Agents; D001786:Blood Glucose; D015725:Fluconazole