Venous Leg Ulcer Clinical Trial
— venedOfficial title:
The Impact of a Pluridisciplinary Education Program on Venous Leg Ulcer Size Reduction: a Randomized Controlled Trial
Background and rationale: Venous leg ulcers (VLU) are slow healing wounds with a recurrence rate of 70% and a 60% risk of becoming chronic. The estimated VLU prevalence in the general population is 3%. Current therapeutic approaches are multifaceted and focus on reducing wound size and improving wound healing as well as preventing ulcer recurrence. They require a pluridisciplinary team of health care professionals from the domains of nursing, medicine, physiotherapy and nutrition. Approximately 70% of VLU patients have a knowledge deficit in regards to therapeutic measures and have difficulties with adherence to treatment protocols. However, there are no published studies describing and evaluating the impact of pluridisciplinary educational interventions on adherence to the treatment plan and wound size reduction in VLU patients. Overall objectives: The objectives of the projected study are to evaluate the effectiveness of nurse-led intervention for high-risk patients with VLU in terms of patient knowledge/therapy adherence and to measure the impact of this intervention on wound size reduction and its evolution over time. Methodology of the planned study: An international multicenter randomized controlled trial with 248 participants in three Swiss French (n= 124) and two Australian (n=124) wound clinics is proposed. The sample size assumptions are based on a two-sided alpha level of 0.05, power of 0.8, and a medium effect size. Univariate and bivariate analysis will be conducted according to the data level and distribution. Expected results and impact: The findings of this study will generate new knowledge and the results will contribute to VLU clinical practice guidelines to enhance patient adherence to therapy. Our results will not only help improving patients' quality of life, but also contribute to reducing health expenditure.
Status | Recruiting |
Enrollment | 148 |
Est. completion date | May 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years or older, - an existing diagnosed open VLU, - ulcer surface >5 cm2 and > 15 cm2, - proficiency in the French language Exclusion Criteria: - Valid informed consent is not or cannot be given |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Geneva | Geneva | |
Switzerland | Centre hospitalier universitaire vaudois | Lausanne | VD |
Switzerland | Cité Génération Maison de santé | Onex | GE |
Lead Sponsor | Collaborator |
---|---|
School of Health Sciences Geneva |
Switzerland,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound size reduction | Measurement of the impact of a pluridisciplinary educative program on the relative Reduction (in %) of wound size in patients with VLU. Wound size will be measured using WoundWorks® imaging device | one year | |
Secondary | Self-care | Self-care score will be evaluated using the validated self care questionnaire (VeLUSET©_FR), | one year | |
Secondary | Effective activity | Effective activity will be measured using GeneActiv device | one year | |
Secondary | wound evaluation | Wound will be evaluated in terms of exudative status, smell, infection status and pain felt. The TIME strategy (T = tissue removal; I = infection control; M = moisture balance; E = edge advancement) proposed by the European Wound Management Association will be applied | one year | |
Secondary | Adherence to lifestyle | Adherence to lifestyle prescriptions, including physical activity, leg elevation, ankle exercises, wearing compression stockings, will be evaluated using a short health questionnaire | one year | |
Secondary | general nutritional status | General nutritional status of patients will be measured using the MNA® questionnaire, a validated assessment tool that identifies people malnourished or at risk of malnutrition | one year | |
Secondary | protein intake | Daily protein intake of participants in g/kg of body weight will be estimated using FFQ questionnaire, a validated tool developed to assess mean nutrient intakes in the population | one year |
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