Diabetes Clinical Trial
Official title:
Improving Diabetic Foot Ulcers With Atorvastatin
Verified date | September 2009 |
Source | Asker & Baerum Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 approximately 15%. Foot ulcers may become complicated by infection or gangrene, and ultimately result in amputation. In addition, foot ulcers have a significant impact on quality of life (QoL). The treatment of diabetic foot ulcers has not made substantial progress in recent years with regards to improved healing although there have been several actions taken to update the process. The current practice consists of wound debridement, treatment of underlying infections and pressure relief. This trial investigates the adjunctive effects of high (80 mg) or low (10 mg) dose atorvastatin to conventional treatment on the healing of diabetic foot ulcers.
Status | Completed |
Enrollment | 13 |
Est. completion date | March 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Asker and Baerum Hospital | RUD | |
Norway | Østfold County Hospital | Sarpsborg |
Lead Sponsor | Collaborator |
---|---|
Asker & Baerum Hospital | Pfizer |
Norway,
Healing of diabetic foot ulcers may be modified by high dose atorvastatin - a 6 month randomised controlled pilot trial European Association for the Study of Diabetes 2008 Johansen OE, Birkeland KI, Jørgensen AP, Orvik E, Sørgård B, Torjussen BR, Ueland T
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the efficacy of atorvastatin in patients with foot ulcers and type 1 or type 2 diabetes mellitus receiving conventional foot ulcer treatment in improving foot ulcer treatment with regards to completely healed DFU, recurrence of DFU or novel DFU | 26 weeks | ||
Primary | Time to complete healing (during 26 weeks of study) | 26 weeks | ||
Primary | Recurrence rate of foot ulcers (during 26 weeks of study) | 26 weeks | ||
Secondary | To assess the efficacy of atorvastatin in patients with foot ulcers and type 1 or type 2 diabetes mellitus receiving conventional foot ulcer treatment in improving: lipid variables and micro-CRP | 26 weeks | ||
Secondary | Cost of DFU treatment from debut to healing (IDUS substudy) | 2008 |
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