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CompletedNCT03454698legulcerUpdated Apr 4, 2019

Education for Venous Leg Ulcer Patients

An interventional study of Education in Interprofessional Education for Venous Leg Ulcer Patients, sponsored by School of Health Sciences Geneva. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-04.

Sponsored by School of Health Sciences Geneva · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Venous leg ulcers (VLU) are slow healing wounds. They have a high recurrence rate and are associated with pain, infection, smell and exudate. 60% of VLU become chronic. Current therapeutic approaches are multifaceted and focus on improving wound healing and preventing recurrences. As those approaches include compression therapy, leg elevation, specific exercises for the foot/ ankle region and a protein rich diet/ nutrition plan a multidisciplinary team of health care professionals such as nursing, physiotherapy, occupational therapy and nutrition specialists. Most persons with VLU have a knowledge deficit in regards to therapeutic measures and hence have difficulties with adherence to treatment protocols/ management plans. It is of utmost importance, and best practice, that the treatment team provides effective patient education and support during the learning phase.

However, there is little evidence and no published studies that describe and evaluate effective multidisciplinary educational interventions that target compliance/ adherence to the treatment plan in patients with VLU. Therefore the investigators propose to develop an evidence-based interprofessional educational intervention and evaluate its feasibility first in a pilot study and subsequently in a randomized controlled trail.

Method/Design: Firstly, the development of an evidence based education intervention in collaboration with an expert panel and secondly a randomized controlled pilot study in one wound care outpatient clinic is proposed. Data will be analyzed using SPSS version 23. Univariate and bivariate analysis will be conducted according to the data level and distribution of the data.

Discussion: The TIEIVLU will firstly develop an evidenced based educational intervention and secondly examine the feasibility of implementing this education intervention in a realistic care context in patients with VLU. The results will inform the final design of a following RCT which will examine the effectiveness of the educational intervention. An intervention that enhances patient adherence to therapy and hence reduces the negative outcomes of VLU would be beneficial to individual patients as well as society as a whole.

Read the detailed description

Background: Venous leg ulcers (VLU) are slow healing wounds. They have a high recurrence rate and are associated with pain, infection, smell and exudate. 60% of VLU become chronic. The signs and symptoms of VLU are not only a burden on those who are affected by it but also on the health care system and society in general. While the prevalence of VLU in the general population is 1%, it rises to 3% in the over 80 age group. The cost of treatment and care for VLU is estimated to be 2 to 3% of the overall health expenditure. Current therapeutic approaches are multifaceted and focus on improving wound healing and preventing recurrences. As those approaches include compression therapy, leg elevation, specific exercises for the foot/ ankle region and a protein rich diet/ nutrition plan a multidisciplinary team of health care professionals such as nursing, physiotherapy, occupational therapy and nutrition specialists. Most person with VLU have a knowledge deficit in regards to therapeutic measures and hence have difficulties with adherence to treatment protocols/ management plans. It is of utmost importance, and best practice, that the treatment team provides effective patient education and support during the learning phase.

However, there is little evidence and no published studies that describe and evaluate effective multidisciplinary educational interventions that target compliance/ adherence to the treatment plan in patients with VLU. Therefore the investigators propose to develop an evidence-based interprofessional educational intervention and evaluate its feasibility first in a pilot study and subsequently in a randomized controlled trail.

Method/Design: Firstly, the development of an evidence based education intervention in collaboration with an expert panel and secondly a randomized controlled pilot study in one wound care outpatient clinic is proposed. Data will be analyzed using SPSS version 23. Univariate and bivariate analysis will be conducted according to the data level and distribution of the data.

Discussion: The TIEIVLU will firstly develop an evidenced based educational intervention and secondly examine the feasibility of implementing this education intervention in a realistic care context in patients with VLU. The results will inform the final design of a following RCT which will examine the effectiveness of the educational intervention. An intervention that enhances patient adherence to therapy and hence reduces the negative outcomes of VLU would be beneficial to individual patients as well as society as a whole.

02

Conditions studied

  • Interprofessional Education for Venous Leg Ulcer Patients
03

In context

Lead sponsor

School of Health Sciences Geneva is the lead sponsor of 22 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • An existing open venous leg ulcer
  • An ankle brachial pressure index (ABPI) between 0.8 and 1.3
  • Age over 18 years
  • Proficiency in the French language

Exclusion criteria

Exclusion Criteria:

  • Valid informed consent is not or cannot be given
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Other
    Contol

    "Usual care" for patients in the CG is defined as follows: Visits to the outpatient wound-care centre as directed by a physician. Wound care performed by the wound expert according to the hospital's own standards. This standard corresponds to the one from the EWMA.

    Other: Education

Interventions

  • OtherEducation

    "Usual care" as described for the CG also applies to the IG. The intervention will consist of giving patients an opportunity to learn about the use of compression bandages, wearing and putting on compression stockings, physical activity, good skin care, and a high-protein, vitamin-rich diet. This group will be supervised by a study nurse, who will not be identical with the nurse in charge of the control group.

06

What researchers measure

Primary outcomes

  1. acceptability of an interprofessional education for venous leg ulcer patients

    acceptability of this elaborated interprofessional education

    Time frame: 3 months

07

Study locations

1 site
  • Cité Génération Maison de santé
    Onex, Canton of Geneva 1213, Switzerland
08

References and documents

Publications

  • Probst S, Allet L, Depeyre J, Colin S, Buehrer Skinner M. A targeted interprofessional educational intervention to address therapeutic adherence of venous leg ulcer persons (TIEIVLU): study protocol for a randomized controlled trial. Trials. 2019 Apr 29;20(1):243. doi: 10.1186/s13063-019-3333-4. PubMed 31036037 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03454698
Lead sponsor
School of Health Sciences Geneva
Responsible party
Sebastian Probst (Clinical Professor, School of Health Sciences Geneva) — Principal investigator
First posted
Mar 6, 2018
Start date
May 1, 2018
Primary completion
Oct 31, 2018
Completion
Dec 31, 2018
Last update
Apr 4, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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