AzTrials
AzTrials

Foot UlcerPhase 2NCT00134550

Improving Diabetic Foot Ulcers With Atorvastatin

A Phase 2 study testing Atorvastatin (10 mg or 80 mg) in people with Foot Ulcer and Diabetes, run by Asker & Baerum Hospital at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Foot Ulcer, Diabetes
What is being tested?
Atorvastatin (10 mg or 80 mg)
How many people
13 participants
Where
2 sitesNorway
Study dates
Feb 2005to Mar 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Asker and Baerum Hospital

    Rud, 1309

  • Østfold County Hospital

    Sarpsborg, 1723

Other trials in Norway

About this study

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.

Read the 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
Being tested
Atorvastatin (10 mg or 80 mg)
Keywords
Diabetes Mellitus, Foot ulcers, Complication, Foot Ulcer, Diabetic
Medical subject headings
Foot Ulcer, Diabetes Mellitus, Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atorvastatin (10 mg or 80 mg)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 26 weeks

  2. Time to complete healing (during 26 weeks of study)

    Measured: 26 weeks

  3. Recurrence rate of foot ulcers (during 26 weeks of study)

    Measured: 26 weeks

Secondary outcomes (2)

  1. 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

    Measured: 26 weeks

  2. Cost of DFU treatment from debut to healing (IDUS substudy)

    Measured: 2008

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionMar 2007
  4. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00134550
Sponsor's protocol ID
The IDUS trial
Status last verified
Sep 2009
First submitted
23 Aug 2005
Last updated
23 Sep 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20923537

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atorvastatin (10 mg or 80 mg) in people with Foot Ulcer and Diabetes, run by Asker & Baerum Hospital at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00134550, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in