Status:
COMPLETED
Improving Diabetic Foot Ulcers With Atorvastatin
Lead Sponsor:
Asker & Baerum Hospital
Collaborating Sponsors:
Pfizer
Conditions:
Foot Ulcer
Diabetes
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
Lower limb complications are a substantial matter in the diabetic population and studies show that the annual incidence of foot ulcers ranges from 1.0-4.1% while the cumulative lifetime incidence is a...
Detailed Description
The diabetic foot ulcer etiology is multiplex and the wound healing is often not very successful due to various reasons. The ulcer's etiology is associated with peripheral vascular disease, autonomic ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00134550
Start Date
February 1 2005
End Date
March 1 2007
Last Update
September 23 2009
Active Locations (2)
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1
Asker and Baerum Hospital
Rud, Norway, 1309
2
Østfold County Hospital
Sarpsborg, Norway, 1723