Improving Diabetic Foot Ulcers With Atorvastatin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00134550|
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : September 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Foot Ulcer Diabetes||Drug: Atorvastatin (10 mg or 80 mg)||Phase 2|
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 neuropathy and endothelial. There may also be present some metabolic conditions that are not optimal for wound-healing, delaying the process even more (hyperglycemia, hyperlipidemia, hyperinsulinemia, pro-coagulative state).
It has been shown that statins may improve these aspects making the use of this as adjuvant therapy in treating diabetic foot ulcers an interesting theory. There is so far not any direct evidence for this, although documentation exists for several other possible associated conditions.
This study aims to elucidate the pleiotropic effects of atorvastatin on the healing of diabetic foot ulcers.
Material and Methods:
This 26-week prospective randomised, open, study will be conducted as a pilot to assess the efficacy of atorvastatin in improving diabetic foot-ulcer healing. Atorvastatin will be given in two dosages (10 mg and 80 mg) and evaluations between these groups will be done with regards to improvement in foot ulcer healing, microcirculation and inflammatory markers.
We aim to include 24 patients with diabetes (both type 1 and 2), over the age of 30, of both genders who have a wound duration of less than 12 months. The patients will be recruited from the diabetic out-patient clinics in two centers (Sarpsborg Hospital and Asker and Baerum Hospital).
We plan to begin the enrolment of eligible patients in autumn 2004. We plan for a 18 month inclusion period and hope to conclude this pilot study by autumn 2006. Results from the study will be presented in international papers or meetings concerning diabetes and complications.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Diabetic Foot Ulcers With Atorvastatin|
|Study Start Date :||February 2005|
|Primary Completion Date :||March 2007|
|Study Completion Date :||March 2007|
- 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 [ Time Frame: 26 weeks ]
- Time to complete healing (during 26 weeks of study) [ Time Frame: 26 weeks ]
- Recurrence rate of foot ulcers (during 26 weeks of study) [ Time Frame: 26 weeks ]
- 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 [ Time Frame: 26 weeks ]
- Cost of DFU treatment from debut to healing (IDUS substudy) [ Time Frame: 2008 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134550
|Asker and Baerum Hospital|
|RUD, Norway, 1309|
|Østfold County Hospital|
|Sarpsborg, Norway, 1723|
|Study Chair:||Odd E Johansen, MD||Asker and Baerum Hospital|