Chronic Venous Insufficiency Circulatory System Venous insufficiency (chronic)(peripheral)
Conditions
Interventions
Current interventions as of 28/02/2020:
Following written consent, at week 0, participants are allocated at random to one of the two arms 1:1 fashion. A randomised sequence from the fr
Sponsors
Cumbria Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical indication to commence, or already started, compression bandaging of the leg. This may due to venous leg ulcer or other qualifying reason. This will be equivalent to a CEAP classification score of C2 or higher (clinical element only – see Appendix 5) 2. ABPI > 0.5, measured within last 12 months. If not yet measured as part of routine clinical care, patients are allowed to be recruited into the trial and ABPI will then be measured. If the measurement is too low, the patient will be withdrawn from the study 3. Adult patients aged > 18 years 4. Mental capacity to give consent
Exclusion criteria
Exclusion criteria: 1. Under the age of 18 years 2. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity 3. Limited life expectancy, i.e. undergoing palliative care 4. Active infection in the leg, incl infected venous leg ulcer, cellulitis or otherwise, that requires systematic antibiotic treatment – or within 1 one week of completing antibiotics course. This includes prophylactic antibiotic use 5. Patients who are participating in another research study involving an investigational product that is related to leg, skin, or a co-morbidity that may influence the function of compression bandaging 6. The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives 7. Ankle brachial index < 0.5, measured within 12 months of baseline visit or at baseline of trial participation 8. Any condition that is contraindicated for the use of any of the compression bandaging used in this trial (including ZnO, Calamine)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 28/02/2020: Pruritus levels in the index leg, measured by the severity of pruritus scale (SPS) weeks 0, 3, 6. Week 3 and 6 are used for comparing performance of the two bandages. Week 0 will be available to deduct any baseline presence of itching. Chi-square test will be used for the Severity of Pruritus Scale score. Mann-Whitney U-test will be used for the visual analogue scale for pruritus , and for the 5D itchiness score. _____ Previous primary outcome measure: Pruritus levels in the index leg, measured by the severity of pruritus scale (SPS) weeks 0, 4, 8. Week 4 and 8 are used for comparing performance of the two bandages. Week 0 will be available to deduct any baseline presence of itching. Chi-square test will be used for the Severity of Pruritus Scale score. Mann-Whitney U-test will be used for the visual analogue scale for pruritus, and for the 5D itchiness score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures 28/02/2020: Patient-reported outcome measures: 1. Pruritus scales: SPS, visual analogue scale, 5D (week 0, 3, 6) 2. Venous disease quality of life: CIVIQ20 (week 0, 3, 6) 3. Patient experience upon application of bandage (week 0, week 3) 4. Patient experience of each bandage (week 3, 6) 5. Patient preference (week 6) Clinical parameters: 1. Skin characteristics and wound status measured with Venous Clinical Severity Score (week 0, 3, 6) 2. Any significant side-effects that required clinical intervention? (week 3, 6) 2.1. Need to either interrupt or discontinue bandage treatment regime? 3. Any generic clinical events? (week 3, 6) 4. Apart from any potential wound dressings, was another product used on the leg? (week 3, 6) 4.1. If so, what product? e.g. Zinc Oxide cream/ointment/paste (including Sudocrem, Desitin) 5. Leg status (week 0, 3, 6): 5.1. Ulcer present: yes/no 5.1.1. If yes, 5.1.1.1. Ulcer location: above calf/calf/below calf 5.1.1.2. Chronicity of ulcer 5.1.1.3. Any evidence on size, if available in medical notes Clinician bandage preference questionnaire (week 6) _____ Previous secondary outcome measures: Patient-reported outcome measures: 1. Pruritus scales: SPS, visual analogue scale, 5D (week 0, 4, 8) 2. Venous disease quality of life: CIVIQ20 (week 0, 4, 8) 3. Patient experience upon application of bandage (week 0, week 4) 4. Patient experience of each bandage (week 4, 8) 5. Patient preference (week 8) Clinical parameters: 1. Skin characterist | — |
Countries
United Kingdom
Outcome results
None listed