drugset / Trial / NCT00134550

Improving Diabetic Foot Ulcers With Atorvastatin

NCT00134550

Phase 2 Completed 13 enrolled Asker & Baerum Hospital Pfizer · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2005-02
Primary completion
2007-03
Completion
2007-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 10 mg
Subject Atorvastatin Small molecule 80 mg