Venous Leg UlcerlegclubNCT04370106
The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes
A study testing Social leg program in people with Venous Leg Ulcer and Social Interaction, run by School of Health Sciences Geneva at 2 sites in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer, Social Interaction
- What is being tested?
- Social leg program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Dec 2023to 31 Aug 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Valid informed consent is not or cannot be given
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
IMAD
Carouge, Canton of Geneva, 1227
Stéphane Coffre, RN, 022 420 22 52, stephane.coffre@imad-ge.ch
Cité Génération Maison de santé
Onex, Canton of Geneva, 1213
About this study
Official title: The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes: a Randomized Controlled Trial
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).
Read more
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.
Read the detailed 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.
- Conditions
- Venous Leg Ulcer, Social Interaction
- Being tested
- Social leg program
- Keywords
- leg club, education, recurrence
- Medical subject headings
- Varicose Ulcer, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social leg programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual 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 | Other | 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. Receives: Other: Social leg program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to therapy
Adherence to therapy, including physical activity, leg elevation, ankle exercises, wearing compression stockings, will be measured in minutes
Measured: 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
Measured: 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.
Measured: six months
Secondary outcomes (6)
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
Measured: six months
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.
Measured: six months
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.
Measured: six months
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.
Measured: six months
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.
Measured: six months
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 Dec 2023 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- School of Health Sciences Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian E Probst, Prof Dr, Principal investigator, HES-SO University of Applied Sciences and Arts Western Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370106
- Sponsor's protocol ID
- social leg program
- Acronym
- legclub
- Status last verified
- Jan 2023
- First submitted
- 28 Apr 2020
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04370106
- Acronym / sponsor ID
- legclub / social leg program
- Conditions
- Venous Leg Ulcer, Social Interaction
- Keywords
- leg club, education, recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- School of Health Sciences GenevaUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual 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 | Other | Other: Social leg programUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Valid informed consent is not or cannot be given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social leg programUsual 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. | Other | Social leg Program |
Primary outcome
Adherence to therapy
Time frame: six months
Adherence to therapy, including physical activity, leg elevation, ankle exercises, wearing compression stockings, will be measured in minutes
Wound healing
Time frame: six months
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
Wound recurrence
Time frame: six months
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.
6 secondary outcomes
Wound Assessment
Time frame: six months
Self care
Time frame: six months
Depression
Time frame: six months
Multidimensional complexity
Time frame: six months
General nutritional status
Time frame: six months
Patient Satisfaction
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian E Probst, Prof Dr principal investigator
HES-SO University of Applied Sciences and Arts Western Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social leg program in people with Venous Leg Ulcer and Social Interaction, run by School of Health Sciences Geneva at 2 sites in Switzerland.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian E Probst, Prof Dr (022 3885600 ext. 5709, sebastian.probst@hesge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to therapy (time frame: six 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?
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 27 Jan 2023.