Venous leg ulcers Circulatory System Venous ulcers
Conditions
Interventions
Current interventions as of 09/02/2024:
The study has a 45-month recruitment period in total (comprising and initial 32 month planned recruitment period plus 13 month extension) including an initial 6
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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 3. Wound-related pain measured using the Visual Analogue Pain Scale (VAS) at baseline, 1, 3, 6, and 12 months 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 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactCatherine Arundel
Outcome results
None listed