Outcomes of Non-infected Diabetic Foot Ulcers With/Without Antibiotics (KADFUT)
Diabetes, Foot Ulcers, Infection
About this trial
This is an interventional treatment trial for Diabetes focused on measuring diabetes, antibiotics, clean foot ulcers
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Active Antibiotic Group
Non antibiotic group
Patients in the antibiotic group will remain on antibiotics until their foot ulcer heals or up to 20 weeks