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

Not Applicable

Recruiting

• Conditions: Venous leg ulcer; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN15014758
• Lead Sponsor: niversity Hospital of South Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-20
• Last Update Posted: 29 April 2019
• Study Completion: 2020-06-05

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 55

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

Exclusion Criteria

1. Non-venous cause of ulceration: peripheral arterial disease (ABPI < 0.8), vasculitis, neuropathy, recent lower limb trauma, chronic dermatitis, pyoderma gangrenosum, malignancy, chronic osteomyelitis or any other lower limb pathology that may be contributing to the ulceration, in the opinion of the investigator.
2. Inability to tolerate or comply with lower limb compression therapy
3. Inability to receive prompt endovenous treatment
4. Unwilling or unable to provide informed consent
5. Current enrolment in another study pertaining to venous ulceration
6. Primary or secondary immunosuppression
7. Previous treatment of the target vein or other venous surgery that may compromise the study, in the opinion of the research team
8. Patient has pre-planned surgical intervention or endovascular procedure scheduled up to 30 days after the index procedure
9. Currently pregnant
10. Duplex evidence of deep venous incompetence or occlusion
11. Clinical evidence of post-thrombotic syndrome
12. Incompetent vein considered too tortuous to allow VenaSealTM treatment
13. Inability to tolerate VenaSealTM treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Lower limb venous disease is measured using the Venous Clinical Severity Score, at baseline, three, six and 12 months<br> 3. Rate of venous recanalization measured using duplex ultrasound at baseline, three, six and 12 months<br> 4. Patient satisfaction is measured using Likert scale measures in a written questionnaire at baseline, three, six and 12 months<br> 5. Adverse events are measured using reports at 12 months<br> 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<br>