The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes
legclub
1 other identifier
interventional
268
1 country
2
Brief Summary
Background and rationale: Venous leg ulcers (VLU) are slow healing wounds with a recurrence rate up to 70% and a 60% risk of becoming chronic. Currently the Swiss health care system does not take in consideration social and educational needs and support for VLU patients who transition from acute care (hospital care, outpatient care) to home based self-care. To fill this gap, this study proposes to create the Social Legs Program (SLP). Overall objectives: The objectives of the proposed study are to evaluate the impact of a frequented SLP for patients with VLU in terms of their therapeutic adherence and wound healing outcomes (wound size and wound recurrence). Methodology of the planned study: A randomized controlled trial with 268 participants in three Swiss French institutions is proposed. Expected results and impact: The findings of this study will generate new knowledge about support and care management of persons with VLU who transition between acute care settings and home care settings. The findings will contribute to the evidence base of clinical practice guidelines for the care of patients with VLU.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2020
CompletedFirst Posted
Study publicly available on registry
April 30, 2020
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedJanuary 27, 2023
January 1, 2023
1.3 years
April 28, 2020
January 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adherence to therapy
Adherence to therapy, including physical activity, leg elevation, ankle exercises, wearing compression stockings, will be measured in minutes
six months
Wound healing
Measurement of the impact of a social leg program on the relative reduction (in percent) of wound size in patients with VLU. Wound size will be measured using WoundWorks® imaging device
six months
Wound recurrence
Measurement of the impact of a social leg program on absolute number of participants experiencing a recurrence (in percent) within six months over number of participants who had a healed VLU.
six months
Secondary Outcomes (6)
Wound Assessment
six months
Self care
six months
Depression
six months
Multidimensional complexity
six months
General nutritional status
six months
- +1 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONUsual care for participants with existing VLU in the CG is defined as visiting the outpatient wound clinic/visits by the community care nurse as prescribed by the physician. Wound healing measurement, therapeutic adherence measurement, wound recurrence measurement, and questionnaires will be provided by the institute's nurses.
Social leg Program
OTHERUsual care as described for the CG will also be provided to the IG. Wound healing measurement, therapeutic adherence measurement, wound recurrence measurement, and questionnaires will be provided by the institute's nurses. After baseline data collection (T0) and random allocation to the intervention group, this usual care will be enhanced by frequenting a social leg program.
Interventions
Usual care as described for the CG will also be provided to the IG. Wound healing measurement, therapeutic adherence measurement, wound recurrence measurement, and questionnaires will be provided by the institute's nurses. After baseline data collection (T0) and random allocation to the intervention group, this usual care will be enhanced by frequenting a social leg program.
Eligibility Criteria
You may qualify if:
- years or older,
- with an existing diagnosed open VLU,
- an ulcer surface \<2 cm2 or having a healed VLU,
- proficiency in the French language
You may not qualify if:
- \- Valid informed consent is not or cannot be given
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
IMAD
Carouge, Canton of Geneva, 1227, Switzerland
Cité Génération Maison de santé
Onex, Canton of Geneva, 1213, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian E Probst, Prof Dr
HES-SO University of Applied Sciences and Arts Western Switzerland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2020
First Posted
April 30, 2020
Study Start
December 1, 2023
Primary Completion
March 30, 2025
Study Completion
August 31, 2025
Last Updated
January 27, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share