The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes

Venous Leg Ulcer Clinical Trial

— legclub  

Official title:

The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04370106
• Other study ID #: social leg program
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: January 2023
• Source: School of Health Sciences Geneva
• Contact: Sebastian E Probst, Prof Dr
• Phone: 022 3885600
• Email: sebastian.probst[@]hesge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. Signs and symptoms such as pain or exudate are not only a burden on those affected but also on the health care system and society in general. The estimated VLU prevalence in the general population is 3%. Treatment cost for VLU is estimated to be 4% of overall health expenditure. Current therapeutic approaches are multifaceted, focus on reducing wound size as well as preventing ulcer recurrence. Depending on the severity of the VLU treatment/care occurs in the hospital setting, outpatient setting or community setting. 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). This program is based on the existing Leg Club (LC) community model in the United Kingdom (UK) and will be adapted for the Swiss context. The SLP is designed to provide an environment for social interaction, peer and nursing/professional support, information sharing and personal involvement. Participation in the SLP will address the need for social and educational support in this patient group and will improve therapeutic adherence and result in enhanced wound healing as well as a reduction of the wound recurrence rate.

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).

Specific aims: The impact of the intervention will be measured in terms of therapeutic adherence and wound healing outcomes as well as multidimensional complexity, wound assessment, patient satisfaction, depression, general nutrition, mobility and quality of sleep.

In addition, the incidence of complications (re-hospitalizations) will be measured (frequency and cost).

Methodology of the planned study: A randomized controlled trial with 268 participants in three Swiss French institutions is proposed. The study participants will be consecutive patients of the participating clinics who fulfill the inclusion criteria. Wound care will be performed according to the institutions standard clinical practice guidelines. Allocation to the intervention group (IG) or the control group (CG) will be concealed. The intervention will consist in participating in the SLP. The social program will provide patients with an opportunity to exchange and learn about the prevention measures such as the use of compression bandages, and how to prevent recurrences, and enhance healing outcomes. A study nurse, who will not be identical to the nurse in charge of the control group, will supervise this group. Due to the intervention being a social program, the study cannot be blinded for either the participants or the staff performing the intervention. The sample size assumptions are based on an adjusted (Bonferroni) two-sided alpha level of 0.05, power of 0.8, and clinically relevant effect sizes and a loss to follow up of 20%. Univariate and bivariate analysis will be conducted according to the data level.

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. Additionally, it is in alignment with the National Strategy on the Prevention of Non-Communicable Diseases 2017 - 2024 establishing prevention work for people with enhanced risks and chronic conditions reinforcing a better social integration.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 268
• Est. completion date: August 31, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older,

• with an existing diagnosed open VLU,

• an ulcer surface <2 cm2 or having a healed VLU,

• proficiency in the French language

Exclusion Criteria:

• Valid informed consent is not or cannot be given

Related Conditions & MeSH terms

• Leg Ulcer
• Social Interaction
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Other:
• Social leg program
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.

Locations

Country	Name	City	State
Switzerland	IMAD	Carouge	GE
Switzerland	Cité Génération Maison de santé	Onex	GE

Sponsors (1)

Lead Sponsor	Collaborator
School of Health Sciences Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to therapy	Adherence to therapy, including physical activity, leg elevation, ankle exercises, wearing compression stockings, will be measured in minutes	six months
Primary	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
Primary	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	Wound Assessment	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	six months
Secondary	Self care	Self-care score will be evaluated using the validated self care questionnaire (Venous Leg Ulcer Self-Efficacy Tool); values: minimum (0) and maximum (300); higher scores mean a better outcome.	six months
Secondary	Depression	Depression score will be evaluated using the validated geriatric depression scale questionnaire; values: minimum (0 ) and maximum (15); lower scores mean a better outcome.	six months
Secondary	Multidimensional complexity	Multidimensional complexity will be evaluated using the validated questionnaire (multidimensional complexity assessment tool, COMID): values: minimum (0 ) and maximum (30); higher scores mean a better outcome.	six months
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; values: minimum ( 0) and maximum (14); higher scores mean a better outcome.	six months
Secondary	Patient Satisfaction	Patient satisfaction will be measured using the validated Patient Benefit Index (PBI) questionnaire; values: minimum (0 ) and maximum (4); higher scores mean a better outcome.	six months