Improving Diabetic Foot Ulcers With Atorvastatin
1 other identifier
interventional
13
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2005
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 23, 2005
CompletedFirst Posted
Study publicly available on registry
August 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedSeptember 23, 2009
September 1, 2009
2.1 years
August 23, 2005
September 22, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Time to complete healing (during 26 weeks of study)
26 weeks
Recurrence rate of foot ulcers (during 26 weeks of study)
26 weeks
Secondary Outcomes (2)
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
Cost of DFU treatment from debut to healing (IDUS substudy)
2008
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asker & Baerum Hospitallead
- Pfizercollaborator
Study Sites (2)
Asker and Baerum Hospital
Rud, 1309, Norway
Østfold County Hospital
Sarpsborg, 1723, Norway
Related Publications (1)
Johansen OE, Birkeland KI, Jorgensen AP, Orvik E, Sorgard B, Torjussen BR, Ueland T, Aukrust P, Gullestad L. Diabetic foot ulcer burden may be modified by high-dose atorvastatin: A 6-month randomized controlled pilot trial. J Diabetes. 2009 Sep;1(3):182-7. doi: 10.1111/j.1753-0407.2009.00031.x. Epub 2009 Jun 2.
PMID: 20923537RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Odd E Johansen, MD
Asker and Baerum Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 23, 2005
First Posted
August 25, 2005
Study Start
February 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
September 23, 2009
Record last verified: 2009-09