Extract

Background and study aims A large number of patients (around 1% of the adult population) suffer from an ulcer (break in the skin surface) near the ankle. In most people, such an injury should heal up within a week or two. However, when there is an underlying problem with the skin, ulcers do not heal and may result in longstanding (chronic), painful, smelly and embarrassing wounds. The ulcers are often due to varicose veins in the legs, which can cause skin breakdown and ulcer formation. To get the ulcer to heal, the current best treatment is to wear a tight compression bandage with multiple layers, with which about 60% of these ulcers will heal within 24 weeks. There is evidence that treatment of the varicose veins by surgery will prevent the ulcer from returning after it has healed. Recent studies have suggested that newer techniques of treating varicose veins, such as injecting a medicine into the varicose vein (sclerotherapy) or treating the vein with heat ablation to seal it (using laser or radiofrequency), in an outpatient setting may help the ulcers to heal more quickly and (like surgery) reduce the chance of the ulcer coming back. These techniques can be carried out in the outpatient setting and are much better tolerated by patients in comparison to surgery. The aim of this study is to see whether early treatment of varicose veins using sclerotherapy or heat ablation helps with healing. Who can participate? Men and women, aged 18 or over, with a leg ulcer and varicose veins. What does the study involve? Patients will be randomly allocated to one of two treatments: either compression bandaging with treatment of varicose veins after the ulcer has healed (the current best treatment), or compression bandaging and early treatment of the veins. Participants will be followed-up for 1 year via monthly telephone calls with the research nurse and will undergo routine leg ulcer care in community or hospital (or both) settings, in accordance with the local standard. Participants will attend a 6-week clinic visit and complete questionnaires at baseline, 6 weeks, 6 months and 12 months. We will look at the number of ulcers healed in both patient groups and the speed at which the ulcers healed. We will also ask the patients to comment on any changes in their quality of life following treatment. Furthermore, we will look at the costs of the two treatments. What are the possible benefits and risks of participating? Both of these treatments are routinely offered to most patients with venous leg ulcers, and therefore the risks of taking part in this study are the same as the risks of having treatment outside of the study. The information gained from the study may help doctors and patients make future decisions as to the best approach (early endovenous treatment compared to standard therapy of compression bandages) to treating venous ulcers in the future. If early treatment of varicose veins improves healing rates in patients with leg ulcers, there will be significant cost savings for the NHS as well as great benefits for the patients. Where is the study run from? Imperial College Trials Unit (ICTU) at Imperial College London (UK). When is the study starting and how long is it expected to run for? The study started in September 2013 and will run for 4 years. Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK). Who is the main contact? Francine Heatley (trial manager) [email protected]

Inclusion criteria

• Venous disease/leg ulcers

Links

• isrctn
• ictrp