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Research on trial - scleroderma

Published on 01 April 2010
Source: Arthritis Today

Dr Tony Redmond: leading our new scleroderma trial

Arthritis Research UK has launched a series of exciting new clinical trials with the aim of providing very practical benefits for patients. Arthritis Today reports on a condition that affect the skin and joints: scleroderma.

Trial No 1: scleroderma

"They’re only a small part of the body, but in the morning when my feet hit the floor they determine what I am going to be able to do that day – if they’re painful I know I won’t be able to do very much.”

That’s scleroderma patient Amanda Thorpe describing the effect that the condition has on one particular part of her body. Diagnosed with diffuse subcutaneous systemic sclerosis three and a half years ago, Amanda, now 41, and retired from the civil service on medical grounds, has the typical thickening of the skin in her arms and legs that leave her stiff and immobile.

She also suffers from severe fatigue, and rarely ventures out of her house in Westcliff-on-Sea in Essex apart from the odd trip with husband Michael – usually in a wheelchair. But despite the severity of the pain and stiffness in her limbs, for Amanda, as for many scleroderma sufferers, one of the worst aspects of the disease is the pain in her feet.

“Standing is so uncomfortable, and I can’t walk for longer than two minutes because of the pain,” she says. “I tried MBTs (Masai Barefoot Technology footwear which provide a rolling movement, mimicking the action of walking barefoot) because they make the rocking motion that my feet can no longer make. But the next day, because the skin is so tight my feet were incredibly sore and painful.”

Scleroderma is a rare but serious connective tissue disorder affecting around 5,000 people in the UK and leads to thickening of body tissues (fibrosis) due to the over-production of collagen. Skin, blood vessels and internal organs become constricted, stiff and damaged. People with scleroderma often have a poor blood supply, and they have an exaggerated response to cold. In Raynaud’s phenomenon (almost all scleroderma patients have Raynaud’s) the blood vessels shut down for minutes and even hours, affecting the body’s extremities such as the toes and fingers.

Foot problems have been overlooked

However, because of the severity of scleroderma, researchers have concentrated more on finding new treatments targeting the whole-body effects than countering the other aches and pains. As a result, foot problems have often been overlooked, and have not been the subject of any previous research. That is now changing, largely due to patient demand, and a new clinical trial, funded by £200,000 from Arthritis Research UK, could soon provide a possible solution to Amanda and the 5,000 other scleroderma sufferers’ painful foot problems.

Researchers at Chapel Allerton Hospital in Leeds are hoping to provide a simple, inexpensive solution by testing the effectiveness of a cushioning, warming insole for reducing pain and poor circulation. Arthritis Research UK senior lecturer in the Foot and Ankle group at Chapel Allerton Hospital Dr Tony Redmond is co-ordinating the clinical trial of 140 patients from Leeds, Manchester and London.

“We set out to have a look at foot problems in scleroderma, and, almost to our surprise, people who we thought would be much more worried about other aspects of the condition said that it was important enough for us to do something about it, because it stopped them doing normal activities,” explained Dr Redmond, a leading academic podiatrist at the Leeds Institute of Molecular Medicine at Leeds University.

A genuinely pragmatic study

“What we are doing is a genuinely pragmatic study. We are testing insoles that are cheap and already commercially available and can be used by anyone – a nurse or a GP – it doesn’t have to be a specialist podiatrist.

"We think this simple intervention could make a big difference to many patients – at very little cost.”

In collaboration with two other UK specialist scleroderma centres – Salford Royal Hospital and the Royal Free Hospital in London – groups of patients will be allocated at random to wear for 12 weeks either the treatment insoles or sham insoles, without the cushioning or thermal properties.

Patients taking part in the trial in Leeds will also take part in an exploratory study in the university’s motion analysis laboratory to help researchers establish the cause of their foot problems. The team believes that the insoles may counteract the loss of the fat pad underneath the foot and will explore the effect of cushioning under the ball of the foot.

The study is 'desperately needed'

Consultant rheumatologist Professor Chris Denton from the Royal Free Hospital, a UK scleroderma expert, holder of a number of Arthritis Research UK grants into the condition, and who is involved in running the London arm of the trial, said the study was “desperately needed.”

“Scleroderma is a condition where it’s always been justifiable to really focus on the life-threatening complication such as lung fibrosis, renal crisis, and pulmonary hypertension,” he said. “Treatment options are now much better, although we cannot cure it, and this reminds us that we need to also focus on the non-life-threatening symptoms, such as foot pain, which is really challenging for our patients.

"This study will also allow us to understand a bit better the main causes of foot pain; whether it’s related to poor circulation or reduction of the fat pad beneath the foot, or the mechanics of the foot, i.e. a change in foot shape.This study is a reflection of the way scleroderma research is progressing.”

For more information on scleroderma you can read our new booklet online (PDF version): Scleroderma

Alternatively please call 0300 790 0400 or email us at for a free paper version.

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