Topic: Primary Care
Conditions
Interventions
Patients are randomised to two groups:
1. Usual care : Compression stockings
2. Excercise programme: Low-to-medium term intensity exercise. Thirty six sessions over a p
Sponsors
Sheffield Health and Social Care NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has at least one new venous leg ulcer with a maximum diameter =1 cm 2. Patient has an ankle brachial pressure index (ABPI) =0.8 (taken within last 3 months) 3. Patient is able and willing to tolerate high compression 4. Patient is aged =18 years
Exclusion criteria
Exclusion criteria: 1. Patient is unsuitable or unable to exercise (nurse/doctor judgement) 2. Patients who are not tolerant of high-level lower-limb compression delivered by compression stockings or multilevel bandaging 3. Patients with insulin-controlled diabetes mellitus 4. Pregnant women 5. Patients with coexisting skin conditions, vasculitis, deep venous occlusion or malignant/atypical ulceration 6. Patients who require major surgery 7. Patients with leg ulcers with a maximum diameter of <1 cm 8. Patients who have had an ulcer at the same site within the previous 3 months (updated 30/07/2015: was previously 6 months) 9. Patients are unable or do not wish to consent to participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcomes of the study are the ones that are going to define if this feasibility study should proceed to a larger randomised controlled trial. These will be: 1. The definition of an appropriate primary outcome variable 2. Compliance of participation of patients randomized to the exercise group 3. Loss to follow-up 4. Patience preferences in regards to the randomization group These will be defined at the trial end (12 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to reference ulcer healed (clinical report - time of healing) 2. Proportion of patients healed (clinical report - assessed at 3, 6 and 12 months post-randomisation) 3. Percentage and absolute change in ulcer size (clinical measurement - measured at baseline, 3, 6 and 12 months post-randomisation) 4. Proportion of time patients are ulcer free (clinical report) 5. Recurrence data will be collected at 3, 6 and 12 months post-randomisation) 6. Health-related quality of life (assessed at baseline, 3, 6 and 12 months post-randomisation using the EQ-5D-5L and VEINES-QOL) 7. Lower-limb cutaneous microvascular function 8. Microvascular assessments using Laser Doppler Fluximetry and Iontophoresis at baseline, 3 months, 12 months post-randomisation 9. Physical fitness ? Senior Fitness Test (physical assessment, at baseline, 3 months and 12 months post-randomisation) | — |
Countries
United Kingdom
Outcome results
None listed