Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134550
Status:
COMPLETED
Last Update Posted:
2009-09-23
First Post:
2005-08-23
Brief Title:
Improving Diabetic Foot Ulcers With Atorvastatin
Sponsor:
Asker Baerum Hospital
Organization:
Asker Baerum Hospital
Study Overview
Official Title:
Improving Diabetic Foot Ulcers With Atorvastatin
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10-41 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 ulcers 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None