Prospective Evaluation of Applied ‘Lite’ Compression for leg ulcer Healing, a pragmatic, multi-centre randomized controlled non-inferiority trial

orth Cumbria Integrated Care NHS Foundation Trust0 个研究点目标入组 92 人开始时间: 2023年3月17日最近更新: 2024年4月29日

试验速览

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•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.

•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).

发起方

orth Cumbria Integrated Care NHS Foundation Trust