Plain English Summary
Background and study aims
Leg ulcers are painful, can cause dangerous systemic infections, and the treatment can be difficult to endure. Therefore, treatments that reduce the time taken for the ulcer to heal are needed. Some ulcers are caused by blood flowing the wrong way down the long veins of the leg, usually as a result of poorly functioning valves. It is known that the usual treatment of compression bandages, wound care and assessment by a specialist leg ulcer nurse helps ulcers to heal. It is not known whether treatment with surgical glue helps ulcers to heal faster, or slower, or no differently than with the usual treatment alone. There has not been any research into the use of surgical glue for this purpose, though other studies have shown that it is a safe, effective treatment for varicose veins of the leg, which are also caused by damaged valves. The aim of this study is to establish whether the surgical glue is also effective for the treatment of leg ulcers.
Who can participate?
Adults aged 18 and older who have venous ulcer of the lower limb.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive usual care, and those in the second group receive the usual care and the surgical glue procedure. 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.
What are the possible benefits and risks of participating?
There are no benefits to taking part in this study. Participating in research like this means that you are helping to generate new evidence that can justify developing and improving treatment for those who will develop leg ulcers in future. Like any medical treatment, the surgical glue procedure has some risks associated with it. These include: allergic reaction, bleeding, abnormal connection between an artery and vein (‘fistula’), blood clot in the deep veins (‘deep vein thrombosis’), swelling of the leg, darkening of the skin (‘hyperpigmentation’), infection, pain, numbness around the area where the needle is introduced, inflammation of the veins (‘phlebitis’), blood clot in one of the arteries in the lung (‘pulmonary embolism’), and scarring. Surgical glue is licensed for use in the United Kingdom, and the risk of serious complications is very low.
Where is the study run from?
University Hospital of South Manchester (UK)
When is the study starting and how long is it expected to run for?
November 2016 to June 2020
Who is funding the study?
Medtronic (USA)
Who is the main contact?
Mr David Riding (Public)
david.riding@manchester.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Mr David Riding
ORCID ID
http://orcid.org/0000-0002-0953-1049
Contact details
Academic Surgery Unit
2nd Floor
Education and Research Centre
University Hospital of South Manchester
Manchester
M23 9LT
United Kingdom
+44 161 292 5842
david.riding@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ISR-2016-10829
Study information
Scientific title
Pilot study of cyanoacrylate occlusion of the lower limb veins in patients with venous leg ulcers
Acronym
Study hypothesis
The aim of this study is to determine if blocking veins with surgical glue may shorten the time taken for ulcers to heal.
Ethics approval
Not provided at time of registration
Study design
Single centre open label pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Venous leg ulcer
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.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
29/11/2016
Overall trial end date
05/06/2020
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
55
Participant 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
Recruitment start date
06/11/2017
Recruitment end date
05/06/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital of South Manchester
Southmoor Road
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
University Hospital of South Manchester
Sponsor details
Research and Development
University Hospital of South Manchester
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 161 291 4565
cathy.spence@uhsm.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Medtronic
Alternative name(s)
Medtronic Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Plans to publish the report of this research in a high-impact peer reviewed journal on 01/06/2020.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Charles McCollum.
Charles.mccollum@manchester.ac.uk
Intention to publish date
01/06/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN15014758_PIS_V2.docx Uploaded 01/04/2019
- ISRCTN15014758_PROTOCOL_21Jun17_V1.pdf Uploaded 01/04/2019