A multicentre randomised research trial assessing the effectiveness and acceptability of a calf muscle exercise device for supportive treatment of venous leg ulcers

Not Applicable

Completed

• Conditions: Venous leg ulcers; Specialty: Dermatology, Primary sub-specialty: Dermatology; UKCRC code/ Disease: Cardiovascular/ Diseases of veins, lymphatic vessels and lymph nodes, not elsewhere classified; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN75319519
• Lead Sponsor: Cumbria Partnership NHS Foundation Trust

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31238798/ results (added 07/09/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-19
• Study Completion: 2020-12-31
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Over the age of 18
2. VLU* of less than 6 months duration
3. Tolerating compression bandaging
4. Able to give consent

*The case definition for VLU is any break in the skin on the lower leg that has been present for 2 weeks or more with a clinical venous aetiology and an ankle brachial pressure of = 0.8 (NICE 2013).

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
4. Active infection in VLU

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Feasibility outcomes:<br> 1. Compliance is measured using an assessment of participant diary entries at the end of the trial intervention period at 12 weeks<br> 2. Recruitment and attrition are measured using final consent numbers and lost at follow-up numbers at the end of the trial<br> 3. Adequacy of duration of follow-up (e.g. in relation to VLU healing) is measured using the number of completely healed ulcers in comparison to the total sample size at the end of week 12<br> 4. Fitness for purpose of data collection methods including across and between care settings is measured using completion of CRF data at the end of week 12 (comparing data for participants from different care settings and recruitment sites<br> 5. Adverse events are measured using the total number adverse events recorded at week 12 for all participants<br>