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

PREVUE: PlantaR flexion Exercise for Venous Ulcer Evaluation, a multi-centre, controlled, prospective, randomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75319519

Enrollment

Registered

2017-05-19

Start date

2017-05-30

Completion date

Unknown

Last updated

2022-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Dermatology, Primary sub-specialty: Dermatology

Interventions

Following written consent patients will be allocated at random to the control or intervention group, using a non-restricted randomised sequence generated for the whole sample using a free ware randomi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Feasibility outcomes: 1. Compliance is measured using an assessment of participant diary entries at the end of the trial intervention period at 12 weeks 2. Recruitment and attrition are measured using final consent numbers and lost at follow-up numbers at the end of the trial 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 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 5. Adverse events are measured using the total number adverse events recorded at week 12 for all participants	—

Measure

Time frame

Feasibility outcomes: 1. Compliance is measured using an assessment of participant diary entries at the end of the trial intervention period at 12 weeks 2. Recruitment and attrition are measured using final consent numbers and lost at follow-up numbers at the end of the trial 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 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 5. Adverse events are measured using the total number adverse events recorded at week 12 for all participants

—

Secondary

Measure	Time frame
1. VLU size is measured with Convatec grid tool (outcome measure used for calculating potential power of this present study) at baseline, 6 and 12 weeks 2. Size and characteristics of VLU, determined with PUSH score at baseline, 6 and 12 weeks 3. Mobility is measured using the LifeSpace questionnaire score at baseline, 6 and 12 weeks 4. Ankle range of motion is measured using a goniometer at baseline, 6 and 12 weeks 5. Ulcer-related Pain is measured using the VAS pain scale at baseline, 6 and 12 weeks 6. Quality of life is measured using the Charing Cross Venous Ulcer Questionnaire at baseline, 6 and 12 weeks 7. Intervention compliance (StepIt arm patients) is measured using an exercise diary kept by participants throughout the study at the end of week 12 8. Participant opinion on trial participation is measured using a satisfaction questionnaire at the end of week 12 9. Patient withdrawal rates due to change in management (e.g. need for surgery) is measured using data on loss to follow-up at baseline, 6 and 12 weeks 10. VLU infection rates are measured using clinical record data and microbiology result data at baseline, 6 and 12 weeks	—

Measure

Time frame

1. VLU size is measured with Convatec grid tool (outcome measure used for calculating potential power of this present study) at baseline, 6 and 12 weeks 2. Size and characteristics of VLU, determined with PUSH score at baseline, 6 and 12 weeks 3. Mobility is measured using the LifeSpace questionnaire score at baseline, 6 and 12 weeks 4. Ankle range of motion is measured using a goniometer at baseline, 6 and 12 weeks 5. Ulcer-related Pain is measured using the VAS pain scale at baseline, 6 and 12 weeks 6. Quality of life is measured using the Charing Cross Venous Ulcer Questionnaire at baseline, 6 and 12 weeks 7. Intervention compliance (StepIt arm patients) is measured using an exercise diary kept by participants throughout the study at the end of week 12 8. Participant opinion on trial participation is measured using a satisfaction questionnaire at the end of week 12 9. Patient withdrawal rates due to change in management (e.g. need for surgery) is measured using data on loss to follow-up at baseline, 6 and 12 weeks 10. VLU infection rates are measured using clinical record data and microbiology result data at baseline, 6 and 12 weeks

—

Countries

England, United Kingdom

Contacts

Public ContactLeon Jonker

leon.jonker@cumbria.nhs.uk+44 (0)176 824 5975

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026