Leg ulcer Circulatory System
Conditions
Interventions
Written informed consent will be taken from the patients. Thereafter, they are randomised to one of two treatment arms (Andoflex or Coban2). Patients will be in the trial for 12 weeks, with outcome me
Sponsors
North Cumbria Integrated Care NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Underlying pathology of leg ulcer is venous or mixed venous-arterial. Recognised co-morbidities that may contribute to the development of leg ulcers (e.g. diabetes, rheumatoid arthritis, peripheral vascular disease) are not an exclusion criterion. 3. At least one leg ulcer (in case of multiple defined ulcers, single largest measurable ulcer will be classed as index ulcer). Leg ulcer defined as any break in the skin on the lower leg that has been present for 2 weeks (from NICE 2013) 4. Tolerating compression bandaging 5. Mental ability to give consent 6. An ankle–brachial pressure index (ABPI) of >= 0.5 – 0.8 taken within the previous 3 months. Where an ABPI measure is not viable, use of locally-approved alternative diagnostic assessments to rule out significant peripheral arterial disease and/or ischaemia, i.e. by pulse palpation and ultrasound diagnostics, toe pressure assessment or arterial imaging. If ABPI or other diagnostic methodology is not indicated or feasible, recorded clinical assessment by qualified clinical staff is allowed (diagnosis and rationale for reduced compression to be recorded at baseline). 7. Patient is allowed to be on compression therapy prior to enrolment.
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, or other condition that in opinion of researcher contraindicates participation 4. Active infection in leg ulcer treated with antibiotics within last 1 week (does not apply for prophylactic antibiotic regimes) 5. Is not willing or able to wear any compression device 6. Pure foot ulcer, ie any ulcer that commences below malleolar region (particularly plantar, digital regions) 7. Enrolled in other interventional research study related to patient’s leg ulcer 8. Previous participation in PEACH trial 9. Awaiting surgical intervention related to vascular system of the lower limbs, planned within three months 10. Wound size that is too small (typically <1 cm²), or too large (larger than single wound grid or extending round the leg) to measure accurately 11. Known intolerance or allergy to materials used in compression bandaging (including zinc oxide, calamine).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Ulcer wound status (healed or not healed) and compression bandage use (used or not used) will be recorded at week 0 , week 6 and week 12 2. Ulcer wound size will be measured with a wound grid device and validated PUSH score at week 0 , week 6 and week 12 3. Ulcer related pain and pruritus will be measured with respective 10-cm visual analogue scales at week 0 , week 6 and week 12. 4. General quality of life will be measured with validated EQ-5D-5L questionnaire at week 0 , week 6 and week 12 5. Ulcer related quality of life will be measured with validated VEINES-QOL questionnaire at week 0 , week 6 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed