Outcomes of Non-infected Diabetic Foot Ulcers With/Without Antibiotics (KADFUT)

Inclusion Criteria:

• Patients will be eligible for study participation if he or she meets the following criteria

  • Male or female age 18-85 years inclusive
  • Have been diagnosed with Type 1 or Type 2 diabetes
  • Must be able to speak and understand English and be able to provide meaningful written informed consent .
  • If female, is nonpregnant (negative pregnancy tests at the baseline visit) and nonlactating.

  • If female, is either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practising one of the following medically-acceptable methods of birth control and agrees to continue with the regimen throughout the duration of the study:

    • Oral, implantable or injectable contraceptives for 3 consecutive months before the baseline visit.
    • Total abstinence from sexual intercourse (≥ 1 complete menstrual cycle before the baseline visit).
    • Intrauterine device
    • Double barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
  • Present with one or more diabetic foot ulcers on or below the malleoli with no clinical signs of infection (using the Infectious Disease Society of America/International Working Group on the Diabetic Foot Guidelines).

Exclusion Criteria:

• Female subjects who are pregnant or breast feeding
• Any known intolerance or allergy or reported adverse reaction to any antibiotics
• Known osteomyelitis
• Patients with foot ulcers with clinical signs of infection
• Ulceration caused primarily by a disease other than diabetes.
• Any other serious disease likely to compromise the outcome of the trial.
• Evidence of critical renal disease (creatinine >300µmol/L)
• Patients taking immunosuppressants or any other preparation which may interfere with healing.
• Participation in another clinical trial in the previous 28 days