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Leg UlcersNCT00184873

Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance in Leg Ulcer Patients

A study testing Health Counseling in people with Leg Ulcers and Varicose Ulcers, run by Radboud University Medical Center at 11 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Leg ulcers are often chronic or recurring complications of peripheral circulation disorders. Patients' lifestyles are known to influence leg ulcer occurrence and circulation disorders in general. Read more about this study

Who is it for?
Any age
Conditions the study is for
Leg Ulcers, Varicose Ulcers
What is being tested?
Health Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
11 sitesNetherlands
Study dates
Jan 2005to Dec 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Venous insufficiency
  • Venous and arterial insufficiency
  • Receiving treatment on outpatient clinics for dermatology at the moment of inclusion or in the past three months before inclusion

Who cannot join

  • Total immobility
  • Insufficient mental capacity
  • Insufficient comprehension of the dutch language

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Netherlands11 sites

  • Jeroen Bosch ziekenhuis

    's-Hertogenbosch, North Brabant, 5323 GV

  • IJssellandziekenhuis

    Capelle aan den IJssel, South Holland, 2906 ZC

  • Elkerliek ziekenhuis

    Deurne, North Brabant, 5751 CB

  • Slingeland ziekenhuis

    Doetinchem, Gelderland, 7009BL

  • St Anna ziekenhuis

    Geldrop, North Brabant, 5664EH

  • Radboud University Nijmegen Medical Center

    Nijmegen, Gelderland, 6500 HB

  • ErasmusMC

    Rotterdam, Zuide Holland, 3015 GJ

  • Ziekenhuis Rivierenland

    Tiel, Gelderland, 4002 WP

  • University Medical Center Utrecht

    Utrecht, Utrecht, 3584 CX

  • Bernhoven ziekenhuis

    Veghel, North Brabant, 5461 AA

  • Vie Curi

    Venlo / Venray, Limburg, 5900 BX

Other trials in Netherlands

About this study

Official title: Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance With Compression Therapy and Prescribed Exercise in Leg Ulcer Patients

Leg ulcers are often chronic or recurring complications of peripheral circulation disorders. Patients' lifestyles are known to influence leg ulcer occurrence and circulation disorders in general. Especially exercise and compliance with compression therapy are key elements in the course of leg ulcer healing and recurrence. Yet many patients demonstrate sedentary lifestyles and non-compliance and current practice offers no systematic approach in the promotion of compliance and physical activity in these patients.

The purpose of the study is testing 'Lively Legs' a compliance promotion program for patients with leg ulcers. The study tests the program on effects regarding:

  • compliance with compression therapy and exercise levels
  • time to leg ulcer recurrence
  • cost effectiveness from a social perspective.
Read the detailed description

The project is a multi centre study, using a randomized controlled design. Patients in the study (n=380) are equally randomized to either the experimental or the control group. Patients in the intervention group receive counseling during a period of six months, in line with the Lively Legs program. Patients in the control group receive regular care. Recruitment takes place within a period of nine months. Data are collected at baseline, directly after the intervention period at 6 months, and at follow-ups at 12 and 18 months. Quality of life is additionally assessed at 3, 9 and 15 months.

The population for this study consists of leg ulcer patients, suffering from peripheral circulation disorders of venous or mixed (venous and arterial) origin. The population is restricted to patients treated at outpatient clinics for dermatology.

Individual counseling is performed by nurses, based on the Lively Legs lifestyle-program for leg ulcer patients. This evidence-based program was systematically developed using the Intervention Mapping framework, thus integrating scientific evidence, relevant theories and patient and care provider expertise. The program aims at improved compliance with compression therapy and prescribed exercise level in all patients.

Social Cognitive Theory provides the theoretical framework and the core methods for the Lively Legs program. Nurses will perform the central role as health counselor. In a maximum of six consultations, they will offer tailored counseling, including compliance and physical activity assessment, identification of relevant determinants of behavior, goal setting, and the application of methods and strategies from the Lively Legs program

Being tested
Health Counseling
Keywords
randomized controlled trial, health-counseling, multi-center study
Medical subject headings
Leg Ulcer, Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health CounselingBehavioural

Study groups in NCT00184873
Study groupRoleWhat they receive
Lifestyle counselingActive comparatorPatients receiving lifestyle counseling
Receives: Behavioral: Health Counseling
Regular careNo interventionPatients receiving regular care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. * Compliance with compression therapy

    Measured: 18 months

  2. * Compliance with exercise prescriptions

    Measured: 18 months

  3. * Leg ulcer recurrence

    Measured: 18 months

Secondary outcomes (2)

  1. * time to next ulcer / ulcer size and time to heal in case of recurrence /duration of ulcer free periods

    Measured: 18 months

  2. * evaluation of the cost effectiveness of the program

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionMay 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00184873
Sponsor's protocol ID
13091966
Other IDs
ZonMw 945-04-058
Status last verified
Aug 2007
First submitted
12 Sep 2005
Last updated
9 Feb 2010
Results posted
No
Data monitoring committee
No

Publications

  • Heinen MM, van Achterberg T, op Reimer WS, van de Kerkhof PC, de Laat E. Venous leg ulcer patients: a review of the literature on lifestyle and pain-related interventions. J Clin Nurs. 2004 Mar;13(3):355-66. doi: 10.1046/j.1365-2702.2003.00887.x.

    PubMed 15009338

  • Persoon A, Heinen MM, van der Vleuten CJ, de Rooij MJ, van de Kerkhof PC, van Achterberg T. Leg ulcers: a review of their impact on daily life. J Clin Nurs. 2004 Mar;13(3):341-54. doi: 10.1046/j.1365-2702.2003.00859.x.

    PubMed 15009337

  • Bartholomew LK, Parcel GS, Kok G. Intervention mapping: a process for developing theory- and evidence-based health education programs. Health Educ Behav. 1998 Oct;25(5):545-63. doi: 10.1177/109019819802500502.

    PubMed 9768376

  • Harper PL, Watson L, Bannon R. Compression ultrasonography for diagnosing deep vein thrombosis. Protocol is safe. BMJ. 1998 May 16;316(7143):1534; author reply 1535. No abstract available.

    PubMed 9616028

  • Kan YM, Delis KT. Hemodynamic effects of supervised calf muscle exercise in patients with venous leg ulceration: a prospective controlled study. Arch Surg. 2001 Dec;136(12):1364-9. doi: 10.1001/archsurg.136.12.1364.

    PubMed 11735861

  • Nelson EA, Bell-Syer SE, Cullum NA. Compression for preventing recurrence of venous ulcers. Cochrane Database Syst Rev. 2000;(4):CD002303. doi: 10.1002/14651858.CD002303.

    PubMed 11034749

  • Yang D, Vandongen YK, Stacey MC. Effect of exercise on calf muscle pump function in patients with chronic venous disease. Br J Surg. 1999 Mar;86(3):338-41. doi: 10.1046/j.1365-2168.1999.00993.x.

    PubMed 10201775

Questions about this trial

What is this clinical trial studying?

A study testing Health Counseling in people with Leg Ulcers and Varicose Ulcers, run by Radboud University Medical Center at 11 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

* Compliance with compression therapy (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00184873, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2010.

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