Leg ulcer Not Specified
Conditions
Interventions
Written informed consent will be taken from the patients. Thereafter, they are randomised to one of two treatment arms (standard care or MedCu copper dressing). Patients will be in the trial for 12 we
Sponsors
North Cumbria Integrated Care NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Women to be of non-childbearing potential (i.e., postmenopausal) 3. Lower limb ulcer sized between 1 and 30 cm2 4. Patients can be newly presenting to or existing users of the specialist service in question 5. Patients with recurrent wounds, including multiple wounds, are eligible; largest eligible (i.e. 30 days and < 1 year from patient becoming aware. 8. Prophylactic systemic antibiotic use is not an exclusion criterion 9. Mental and physical ability to give consent and complete study activities 10. Pure foot ulcer, i.e. any ulcer that commences below the malleolar region (particularly plantar, digital regions) 11. Underlying pathology of leg ulcer can be venous, mixed venous-arteria, arterial, or through different underlying aetiology. Recognised comorbidities that may contribute to the development of leg ulcers (e.g. diabetes, rheumatoid arthritis, peripheral vascular disease) are not an exclusion criterion. 12. For leg ulcers: patient is suitable for, and willing to wear, compression therapy, or valid clinical reason why they should not be prescribed compression therapy.
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 the opinion of the researcher contraindicates participation 4. Active infection in leg ulcer treated with systemic antibiotics within last 1 week (does not apply for prophylactic antibiotic regimes) 5. Enrolled in other interventional research studies related to patient’s lower limb ulcer 6. Previous participation in the CUPRA study 7. Awaiting significant surgical intervention related to the vascular or skeletal system of the lower limbs, planned within 3 months (i.e., 12-week trial period) 8. Known intolerance or allergy to materials used in MedCu copper dressing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer wound status (healed or not healed) and dressing (used or not used, and which type) will be recorded at week 0, week 4, week 8 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ulcer wound size will be measured with the Healthy io App (digital wound size measurement) and validated PUSH score questionnaire at week 0, week 4, week 8 and week 12 2. General quality of life will be measured with validated EQ-5D-5L questionnaire at week 0 and week 12 3. Ulcer-related symptoms will be measured with validated VEINES-Sym questionnaire at week 0, week 4, week 8 and week 12 | — |
Countries
England, United Kingdom
Contacts
Public ContactLeon Jonker
Outcome results
None listed