Tuesday, 26 May 2015

Does aspirin hold the key to improving leg ulcers?

Over the years the humble aspirin has been found to possess many medical benefits and uses, and now researchers at SPHPM may be close to discovering another. If so, the discovery would be welcomed by sufferers of venous leg ulcers (VLU) and ease financial burdens on the health system.

Lead researcher Dr Carolina Weller is currently conducting a study (ASPiVLUthat aims to ascertain whether a low-dose (300mg) of aspirin can be routinely prescribed to people diagnosed with VLU to improve healing time and prevent reoccurrence.

“An estimated 400,000 Australians suffer from venous leg ulceration which is more common in older people – this translates to around $2-3 billion in health care costs,” Dr Weller said.

“With an ageing population, and growing obesity and diabetes epidemics - all risk factors for developing VLUs – this study has the potential to benefit a significant proportion of Australia’s population.”

Chronic VLU wounds present on the lower limbs, causing damage to the tissue in the ankle region. Wounds take months to heal and 30-50 per cent of VLUs remain unhealed after two years.

One in three patients suffering from VLU will experience 10 or more episodes of the condition in their lifetime – reoccurrence rates are placed between 30 to 80 per cent. A 2004 study found that almost half of venous ulcers reoccurred by the fifth year from the initial healing, and that it is not uncommon for them to return within only three months of healing.

“Current best practice involves compression bandaging therapy – it is hoped that by adding a 300mg dose of aspirin in conjunction to compression therapy that healing rates will be improved and discomfort somewhat eased,” Dr Weller said.

“If aspirin is proven to speed up the healing time for VLU sufferers this would be a significant breakthrough for this common and painful problem in the community, especially as aspirin is generally safe, well tolerated and widely available.”

ASPiVLU will be conducted as a double-blind, randomised controlled trial, consisting of 12 weeks of standardised, weekly compression therapy in combination with 12 months of daily study drug (Aspirin 300mg or placebo). Recruitment for approximately 260 participants from wound clinics around the country is still being conducted.

Participants must be over 40 years old, not taking routine aspirin, with an ulcer that has existed for at least six weeks in the presence of chronic venous insufficiency. The primary endpoint is time to ulcer healing. Secondary endpoints include ulcer recurrence rate, quality of life (EQ-5D-5L questionnaire and wound pain), measurement of various biomarkers of inflammation and platelet activation to understand potential mechanisms, adverse events (ie. safety of the intervention), and intervention compliance (both study drug and compression therapy).

The study will be completed by December 2017 and is funded by the National Health and Medical Research Council.

There are two other planned or on-going randomised controlled trials (RCTs) relevant to the research question. AVURT (Aspirin for Venous Ulcers: Randomised Trial) in UK and the Aspirin4VLU (Low Dose Aspirin for Venous Leg Ulcers) in NZ.

Chief Investigators of all three aspirin RCTs will work collaboratively to form the Aspirin for Venous Leg Ulcers Collaborative (AVLUC).

The collaborative will collate individual patient data (IPD) meta-analyses of randomised controlled study data that addresses the broad question: is Aspirin an effective and safe treatment for people with venous leg ulcers?

For more information on the study or for information on taking part, please visit the ASPiVLU website: www.med.monash.edu.au/sphpm/aspivlu-study.html
or email carolina.weller@monash.edu or med-aspivlu@monash.edu

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