Status:
UNKNOWN
Outcomes of Non-infected Diabetic Foot Ulcers With/Without Antibiotics
Lead Sponsor:
King's College Hospital NHS Trust
Conditions:
Diabetes
Foot Ulcers
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The overall objective is to investigate whether antibiotics in the treatment of clinically clean neuropathic and ischaemic ulcers in diabetic foot patients could reduce the incidence of infection and ...
Detailed Description
Trail Procedures Visit 0 Screening, Randomisation and Initial Treatment; 1. The researcher will assign a screening number. 2. Medical history and demographics will be recorded. 3. Physical examinatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT01418456
Start Date
August 1 2011
End Date
February 1 2012
Last Update
August 17 2011
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