A prospective single blind randomised controlled study to compare the outcomes of patients with diabetes and clinically non-infected ischaemic and neuropathic foot ulcers treated with and without oral antibiotics - Outcomes of non-infected diabetic foot ulcers with/without antibiotics

King's College Hospital NHS Foundation Trust0 个研究点目标入组 166 人开始时间: 2011年4月11日最近更新: 2019年12月16日

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•Male or female age between 18-85 years inclusive
•Has 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.
•Present with one or more diabetic foot ulcer/s on or below malleoli with no clinical signs of infection as indicated by the Infectious Disease Society of America/International Working Group on the Diabetic Foot Guideline.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 166
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 166

•Patients should not have been taking antibiotics for at least one week prior to entry into the study
•Female patients who are pregnant or breast feeding.
•Any known intolerance or allergy or reported adverse reaction to any antibiotics with the exception of penicillin allergies.
•Known osteomyelitis, as indicated by it being possible to probe to bone at the base of the ulcer.
•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
•Patients with foot ulcers which have clinical signs of infection.
•The most appropriate antibiotic and alternative IMP (section 3.2) are
•contraindicated

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