Surgical glue for the treatment of damaged veins in patients with venous leg ulcers

INTERVENTION: Cyanoacrylate (surgical glue) occlusion plus compression bandaging, wound care and specialist leg ulcer clinician review versus compression bandaging, wound care and specialist leg ulcer clinician review only. Patients are randomised 1:1 using a computerised system. The surgical glue procedure is performed using a small amount of local anaesthetic and is carried out with ultrasound scan guidance. The procedure is as follows: 1. The patient may feel some minor pain or stinging as a local anaesthetic injection is used to numb the site where the surgeon will access the vein. 2. Once the area is numb, the surgeon will insert a catheter (i.e., a small hollow tube) into the leg vein. The patient may feel some pressure as the catheter is placed. 3. The catheter will be placed in specific areas along the diseased vein to deliver small amounts of the surgical glue. The patient may feel a mild sensation of pulling or tugging. The surgeon will use an ultrasound scanner during the procedure to guide and position the catheter correctly. 4. After treatment, the catheter is removed and a dressing is placed over the puncture site 5. It is expected that patients will return to normal activity immediately after the procedure The participant usually needs to spend around 3‐4 hours in hospital for pre‐ and post‐procedural checks and monitoring. The procedure itself takes between 30 and 60 minutes. Patients randomly allocated to the control group just receive compression bandaging , wound care and specialist leg ulcer clinician review. This is the routine care for all leg ulcer patients. Participants randomly allocated to receive the surgical glue treatment are asked to return at three, six and 12 months after their procedure to undergo further ultrasound scans. At these appointments, they are asked to complete a questionnaire asking them about their symptoms. Patients randomly allocated to usual care only will be asked to complete the same questionnaires by post or online. CONDITION: Venous leg ulcer ; Injury, Occupational Diseases, Poisoning ; Venous leg ulcer PRIMARY OUTCOME: 1. Rate of healing in leg ulcer surface area is measured using tracings of the ulcer area every seven days (+/‐ 2 days) until the ulcer has healed, in the opinion of the reviewing clinician; 2. Time to healing is measured by recording the number of days between the randomisation date and the day on which the clinicians see that the wound has healed; INCLUSION CRITERIA: 1. Venous ulcer of the lower limb at least 2cm2 (CEAP classification C6) 2. Ulceration present for >6 weeks and <6months despite treatment 3. Ipsilateral lower limb vein incompetence of >0.5 seconds duration, confirmed by venous duplex imaging 4. Aged =18 years 5. Willing and able to provide informed consent 6. Ipsilateral ankle‐brachial pressure index =0.8 at the time of randomisation SECONDARY OUTCOME: 1. Quality of life, self‐assessment of health, and severity of symptoms is measured using EQ‐5D and VEINES‐QoL scores 6,7 at baseline, three, six and 12 months; 2. Lower limb venous disease is measured using the Venous Clinical Severity Score, at baseline, three, six and 12 months; 3. Rate of venous recanalization measured using duplex ultrasound at baseline, three, six and 12 months; 4. Patient satisfaction is measured using Likert scale measures in a written questionnaire at baseline, three, six and 12 months; 5. Adverse events are measured using reports at 12 months; 6. Health economic analysis is measured using the cost and frequency of visits to wound care and outpatient clinic, district nurse visit costs, inpatient treatment costs and costs of complications of the treatment or of non‐healing ulcers at baseline, three, six and 12 months;