Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT00134550
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 etc).
* 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 normal.
* 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 the trial.
* 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 normal.
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT00134550
Study Brief:
Protocol Section:
NCT00134550