Treating leg ulcers within two weeks by closing the defective veins improves healing by 12% compared with standard treatment, new findings show
The research, led by Imperial College London and funded by the National Institute for Health Researchstudied 450 patients in the UK with the most common type of leg ulcer known as a venous ulcer.
These ulcers are caused by poor circulation in the lower leg and are often due to defective veins in the leg called varicose veins. These allow blood to flow in the wrong direction – down the legs and feet. This causes the blood pressure in the veins in the lower leg to increase, and these vessels swell and damage the skin.
Leg ulcers can significantly affect the patient’s quality of life and in severe cases can lead to the loss of part of the limb Professor Alun Davies Study author
This results in painful open sores that take many months to heal or in some cases never heal. It is estimated that the NHS manages 731,000 leg ulcers each year, the majority of which are venous. These leg ulcers are more common in obese people and the elderly – around one in 50 people over the age of 80 are thought to have a venous leg ulcer.
Because ulcers can take a long time to heal – and lead to serious complications such as amputation – some estimates suggest that treating and managing them costs the NHS £1.94 billion a year.
Lasers seal the vein
In the new randomized controlled trial, published in New England Journal of Medicinehalf of the patients received treatments within two weeks to treat the varicose veins.
They are usually done under local anesthesia and involve a surgeon destroying or closing the vein by injecting detergent foam into the vein, using a laser or heat to destroy the vessel, or glue to seal it.
In the study the other half of the patients received treatment to treat the varicose veins after their ulcer had healed or after six months if their ulcer was still present. All patients were asked to wear compression stockings, which force blood back into the leg.
Faster healing
The results showed that in patients who received treatment for varicose veins within two weeks, their ulcers healed in 56 days, compared to 82 days in the group whose treatment was delayed.
Professor Alun Davies, lead author of the study from the Department of Surgery and Cancer at Imperial, said: “Leg ulcers can significantly affect a patient’s quality of life and in severe cases can lead to the loss of part of their limb. They also represent a huge cost to the NHS. However, at the moment, most patients are only offered compression stockings without being referred for treatment that addresses the root of the problem – the faulty vein.”
He added that until now there has been no robust trial to assess whether treatments to close the vein are effective.
“With this trial we have shown that with early intervention you improve leg ulcer healing and help a patient recover faster. We recommend that patients be referred to a vascular clinic after being diagnosed with a venous ulcer to see if they would be suitable for early treatment.”
Leg ulcers on the rise
In the trial, 450 patients diagnosed with venous leg ulcers were treated at 20 centers across the UK. Half were randomly assigned to receive treatment to close the damaged vein within two weeks, while the other half were randomized to receive the treatment after the ulcer had healed. Patients were followed up for one year.
The results showed that, after 24 weeks, ulcer healing rates were 85.6 percent in the group that received rapid treatment, compared to 76.3 percent in the group that received delayed treatment.
The authors acknowledge that all patients in the trial received optimal treatment and say that more research is needed into the problem of leg ulcers, especially treatment pathways.
Francine Heatley, study trial leader from the Department of Surgery and Cancer at Imperial, said: “As our population ages and obesity increases, leg ulcers look set to become an increasing problem for patients and the NHS. We need to find the most effective and cost-effective method of treating this condition.”
The team added that further analysis showed that early treatment for vein destruction was cost-effective. This work will be published soon.
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The work was funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Program (project number 11/129/197), with support from the NIHR Imperial Biomedical Research Center
‘A Randomized Trial of Early Endovenous Ablation in Venous Ulceration’ by M. Gohel et al. published in the New England Journal of Medicine
