ABOUT THIS STUDY
- Provision of a written informed consent at the enrolment visit
- Men or women above 30 years of age
- Fertile women need to take contraceptives or have to be sterilised
- Diagnosed with any diabetes mellitus type 1 or type 2
- Present foot ulcer with an ulcer duration <= 12 months
- Intolerance to statins at any time in the past.
- Unwillingness to participate
- A history of alcohol or drug abuse within the last 2 years
- Foot ulcer with the etiology from vasculitis, pyoderma gangrenosum, angiodermatitis
necroticans (hypertensive ulcer), necrobiosis lipoidica, hydrostatic pressure/venous
insufficiency or any neoplasms (basalioma, kaposis sarcoma, squamous cell carcinoma
- History of drug-induced hepatitis or previous liver enzyme elevations (> 3 times the
upper limit of normal) while taking statins.
- History of drug-induced creatine phosphokinase (CPK) > 3 times the upper limit of
- Critical limb ischemia that requires re-vascularisation procedures within 2 months
- Brachial-ankle index < 0.5
- Other serious or unstable medical or psychological conditions that, in the opinion of
the investigator, would compromise the patient's safety or successful participation in
- Any clinically significant abnormality identified in the enrolment medical history,
physical examination, laboratory test which, in the judgement of the investigator,
would preclude safe completion of the study.
- Active liver disease or hepatic dysfunction defined as ALAT or ASAT elevations > 2
times the upper limit of normal or total bilirubin > 1.5 times the upper limit of
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