NCT00134550

Improving Diabetic Foot Ulcers With Atorvastatin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Asker & Baerum Hospital · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

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 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). Study Plan: 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.

Conditions

• Foot Ulcer
• Diabetes

Interventions

Type	Name	Description
DRUG	Atorvastatin (10 mg or 80 mg)

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2005-08-25
• Last updated: 2009-09-23

Locations

2 sites across 1 country: Norway