Improving Diabetic Foot Ulcers With Atorvastatin

September 22, 2009 updated by: Asker & Baerum Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • RUD, Norway, 1309
        • Asker and Baerum Hospital
      • Sarpsborg, Norway, 1723
        • Østfold County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
26 weeks
Time to complete healing (during 26 weeks of study)
Time Frame: 26 weeks
26 weeks
Recurrence rate of foot ulcers (during 26 weeks of study)
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
26 weeks
Cost of DFU treatment from debut to healing (IDUS substudy)
Time Frame: 2008
2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asker & Baerum Hospital

Collaborators

Pfizer

Investigators

  • Study Chair: Odd E Johansen, MD, Asker and Baerum Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

August 23, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (ESTIMATE)

August 25, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2009

Last Update Submitted That Met QC Criteria

September 22, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The IDUS trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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