Condition category
Circulatory System
Date applied
08/05/2014
Date assigned
08/05/2014
Last edited
08/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic venous insufficiency (CVI) is a medical condition where the veins cannot pump enough blood back to the heart, and usually affects the legs. Some patients develop leg ulcers, which can cause pain, social isolation, inability to move, and reduced quality of life. Treatment of venous ulcers places a huge financial burden on the National Health Service. Compression stockings are often used to treat venous ulcers. While they work very well, ulcers frequently come back. Some patients can also benefit from venous surgery, but ulcers frequently come back and many patients are reluctant to undergo surgery. Different therapies are therefore needed. Supervised exercise training might be useful in addition to compression therapy in the prevention and treatment of venous ulcers. Exercise is a low-cost, low-risk, and effective strategy for improving physical and mental health. However, little is currently known about the practicality and usefulness of supervised exercise training used in combination with compression in patients with venous ulcers. We have designed a study to find out the possible benefits of supervised exercise training and compression stockings in patients with venous ulceration, to see if a larger study would be possible.

Who can participate?
Eighty patients with new venous ulcers can take part in this study.

What does the study involve?
Patients will be randomly assigned to either receive usual care (i.e., wear compression stockings), or to take part in a 12-week exercise programme and wear compression stockings. Exercising participants will undertake three sessions of supervised exercise each week (a combination of walking, cycling and leg strength and flexibility exercises). Patients will be followed-up until 1 year after completing the study.

What are the possible benefits and risks of participating?
Possible benefits to be explored include improved healing rate and time, reduced complications and higher quality of life. This is a low risk study, as all participants will be screened before the exercise programme and the programme includes a fully-supervised, moderate-intensity exercise.

Where is the study run from?
The study is run from Sheffield Hallam University in association with the Sheffield Health and Social Care NHS Foundation Trust (UK). Additional recruitment is undertaken by University of Lincoln in association with Lincolnshire Community Health Services NHS Trust (UK).

When is the study starting and how long is it expected to run for?
May 2014 to May 2017.

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Who is the main contact?
Dr Markos Klonizakis
m.klonizakis@shu.ac.uk

Trial website

https://legulcerstudy.wordpress.com/

Contact information

Type

Scientific

Primary contact

Miss Emma McIntosh

ORCID ID

Contact details

The Centre for Sport and Exercise Science
Faculty of Health and Wellbeing
City Campus
Howard Street
Sheffield
S1 1WB
United Kingdom
-
E.mcintosh@shu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16665

Study information

Scientific title

Exploring the Feasibility of Implementing a Supervised Exercise Training and Compression Hosiery Intervention in Patients with Venous Ulceration

Acronym

FISCU

Study hypothesis

Is a randomised controlled trial comparing supervised exercise training and compression therapy versus compression therapy only feasible in patients with venous ulceration?

Ethics approval

NRES Committee Yorkshire & The Humber; ref. 14/YH/0091

Study design

Randomised; Interventional; Design type: Screening

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Primary Care; Subtopic: Not Assigned; Disease: All Diseases

Intervention

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 period of 3 months.; Follow Up Length: 12 month(s); Study Entry : Registration and One or More Randomisations

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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)

Overall trial start date

19/05/2014

Overall trial end date

18/05/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Participant 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

Recruitment start date

21/07/2014

Recruitment end date

21/05/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Hallam University
Sheffield
S1 1WB
United Kingdom

Trial participating centre

University of Lincoln
Lincoln
LN6 7TS
United Kingdom

Sponsor information

Organisation

Sheffield Health and Social Care NHS Foundation Trust (UK)

Sponsor details

c/o Yiwei Harland
Fulwood House
Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Publications will be protocol (under submission), physiological data (microcirculation) and overall study outcomes.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26445318

Publication citations

Additional files

Editorial Notes