Compression therapies for the treatment of venous leg ulcers

Not Applicable

• Conditions: Venous leg ulcers; Circulatory System; Venous ulcers

• Registration Number: ISRCTN67321719
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37237393/ (added 30/05/2023) 2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37964358/ process evaluation (added 16/11/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-14
• Last Update Posted: 15 July 2024
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 637

Inclusion Criteria

1. =1 venous leg ulcer
2. Ankle:brachial pressure index (ABPI) =0. 8 (taken within the previous 3 months or where an ABPI is not viable, use of locally-approved alternative assessments to rule out peripheral arterial disease i.e. pulse palpation and doppler ausculation toe pressure assessment or arterial imaging also taken within the last 3 months)
3. Able to tolerate full compression
4. Aged =18 years

Exclusion Criteria

1. Unwilling to wear full compression
2. Leg ulcers of non-venous aetiology (e.g. arterial or rheumatoid)
3. significant peripheral vascular disease which contraindicates full compression ( requiring an APBI of at least 0.8)
4. Ulcers confined to the foot
5. Lacks capacity or willingness to provide consent to participate in the trial
6. Currently participating in another study evaluating treatments for their venous leg ulcer
7. Known allergy to any trial product
8. Previously recruited for this trial
9. Deemed to be not clinically appropriate to take part in the trial (at clinician discretion)
10. On a waiting list for endovenous ablation and is expected to have surgery within 28 days

Added 27/08/2021:
10. Planned treatment to close/remove incompetent superficial veins (e.g. via endovenous ablation, sclerotherapy) within 28 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to healing of the reference ulcer, defined as 'complete epithelial cover in the absence of a scab with no dressing required. This will be measured by blinded assessment (by two independent blinded assessors, and where there is any disagreement in review, a third review may be completed) of digital images taken at baseline and when the treating nurse regards the reference ulcer as healed

Secondary Outcome Measures

Name	Time	Method
1. Health-related quality of life measured using the VEnous INsufficiency Epidemiological and Economic Study - Quality of Life (VEINES-QOL) and the EuroQol 5-dimension 5-level quality of life questionnaire (EQ-5D-5L) at baseline, 1, 3, 6, and 12 months<br>2. Resource use measured using a set of questions recording the ulcer-related care from the NHS within the past 3 months at 3, 6, and 12 months<br>3. Wound-related pain measured using the Visual Analogue Pain Scale (VAS) at baseline, 1, 3, 6, and 12 months<br>4. Participant adherence and ease of treatment use measured using a set of questions assessing views on the compression treatments, volume of treatment use, and reasons for reduced dose at 1, 3, 6 and 12 months<br>5. Incidence of clinical events such as reference leg healing, ulcer recurrence, amputation, admission, and discharge or death will also be recorded if and when they occur