Improving Diabetic Foot Ulcers With Atorvastatin

NCT ID: NCT00134550

Last Updated: 2009-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2007-03-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Atorvastatin (10 mg or 80 mg)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Asker & Baerum Hospital

OTHER

Sponsor Role: lead

Responsible Party

Odd Erik Johansen

Principal Investigators

Odd E Johansen, MD

Role: STUDY_CHAIR

Asker and Baerum Hospital

Locations

Asker and Baerum Hospital

Rud, , Norway

Østfold County Hospital

Sarpsborg, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 20923537 (View on PubMed)

Related Links

http://www.easd.org/easdwebfiles/annualmeeting/44thmeeting/Posters.pdf

EASD

Other Identifiers

The IDUS trial

Identifier Type: -

Identifier Source: org_study_id