A pilot multi-centre, prospective, randomised, controlled crossover trial assessing patient and clinician impression of different two-layer compression therapy options

Cumbria Partnership NHS Foundation Trust0 个研究点目标入组 44 人开始时间: 2019年2月15日最近更新: 2020年6月22日

适应症

试验速览

•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 If the measurement is too low, the patient will be withdrawn from the study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

•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)

发起方

Cumbria Partnership NHS Foundation Trust