Using exercise as a prevention tool for venous leg ulcers

Exploring the feasibility of using an exercise-based, self-managed, lifestyle intervention for venous leg-ulcer prevention in adults with a venous leg-ulcer history (FISCU III)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16412894

Enrollment

Registered

2025-07-07

Start date

2025-08-01

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Venous leg ulcers Circulatory System

Interventions

Exercise lifestyle intervention: 12 months of self-managed exercise programme with embedded behaviour support, followed twice per week. Standard treatment: Compression bandages or hosiery as prescri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Recently (e.g. 3-months) healed from a leg ulcer of primarily venous aetiology (e.g. with ankle brachial pressure index (ABPI) >= 0.8) 2. Able/willing to tolerate lower-limb compression

Exclusion criteria

Exclusion criteria: 1. Do not have the cognitive ability to complete the study assessments (clinician’s judgement) 2. Pregnant 3. Require major surgery within 3 months from eligibility assessment

Design outcomes

Primary

Measure	Time frame
1. Recruitment rates will be measured as rate of invited participants who are eligible and consenting by 12 months since the start of the project. 2. Attrition rates will be established as discontinuation of intervention and loss to follow-up measurement until the end of follow up at 12 months. 3. Suitability of measurement procedures will be evaluated by completion rates and reasons for missing data at the end of follow up at 12 months. 4. The acceptability of FISCU Intervention will be assessed by using session compliance data at the end of follow up at 12 months. 5. Exercise safety will also be assessed by exploring reasons for drop-out from the intervention and the number and type of adverse events that occur in each group at the end of follow up at 12 months.	—

Measure

Time frame

1. Recruitment rates will be measured as rate of invited participants who are eligible and consenting by 12 months since the start of the project. 2. Attrition rates will be established as discontinuation of intervention and loss to follow-up measurement until the end of follow up at 12 months. 3. Suitability of measurement procedures will be evaluated by completion rates and reasons for missing data at the end of follow up at 12 months. 4. The acceptability of FISCU Intervention will be assessed by using session compliance data at the end of follow up at 12 months. 5. Exercise safety will also be assessed by exploring reasons for drop-out from the intervention and the number and type of adverse events that occur in each group at the end of follow up at 12 months.

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Contacts

Public ContactMarkos Klonizakis

heartresearchuk@shu.ac.uk+44 1142256000

Outcome results

None listed

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