Chronic Venous DiseaseNCT07787065
Effectiveness of a Nursing Intervention Program for Patients Undergoing Ultrasound-Guided Foam Sclerotherapy
A study testing Structured Nursing Intervention Program in people with Chronic Venous Disease, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Chronic venous disease can cause pain, swelling, functional limitations, and reduced health-related quality of life. Ultrasound-guided foam sclerotherapy is commonly used to treat venous insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Disease
- What is being tested?
- Structured Nursing Intervention Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSpain
- Study dates
- 9 Oct 2020to 16 Dec 2024
- 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
- Patients with chronic venous insufficiency undergoing ultrasound-guided sclerotherapy, with or without active lower-extremity ulcers.
- Patients able to attend all scheduled sessions during the study period.
- Patients who provided written informed consent after receiving
Who cannot join
- Patients who required hospital admission or discontinued participation during the study period.
- Patients who, because of neurological, psychological, or psychiatric conditions, were unable to continue attending the scheduled sessions.
- Accepts Healthy Volunteers: No Sex: All Gender Based: No Minimum Age: 18 Years Maximum Age: No Limit (N/A)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eficacia de un Programa de intervención Enfermera Para Pacientes Sometidos a Escleroterapia de Vena Safena Interna
Chronic venous disease can cause pain, swelling, functional limitations, and reduced health-related quality of life. Ultrasound-guided foam sclerotherapy is commonly used to treat venous insufficiency. This randomized controlled trial evaluated whether a structured nursing intervention program, in addition to usual care, improved clinical severity and health-related quality of life in adults undergoing ultrasound-guided foam sclerotherapy at Vall d'Hebron University Hospital.
Participants were randomly assigned to usual care or to the nursing intervention program. The program included nursing assessment and education before the procedure, support during treatment, telephone follow-up on the following day, guidance on compression and self-care, access to telephone support, and scheduled follow-up. Clinical severity was assessed using the Venous Clinical Severity Score (VCSS), and health-related quality of life was evaluated using the Chronic Venous Insufficiency Questionnaire (CIVIQ-20). Satisfaction with care was also assessed in the intervention group.
- Conditions
- Chronic Venous Disease
- Being tested
- Structured Nursing Intervention Program
- Keywords
- Ultrasound-Guided Foam Sclerotherapy, Nursing Intervention, Advanced Practice Nursing, Venous Clinical Severity Score, Health-Related Quality of Life, CIVIQ-20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Nursing Intervention ProgramOther
The structured nursing intervention program was delivered in addition to usual care. It included a nursing consultation before the procedure with clinical assessment and individualized education; support during the sclerotherapy procedure; telephone follow-up on the following day; guidance on compression therapy, self-care, and warning signs; access to telephone support; and scheduled follow-up at three weeks and six months. Ultrasound-guided foam sclerotherapy was clinically indicated background treatment and was not assigned by the study.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | No intervention | Participants received the usual outpatient care associated with ultrasound-guided foam sclerotherapy. They did not receive the structured nursing intervention program evaluated in this study. The sclerotherapy procedure was part of their clinically indicated treatment and was not assigned by the study. |
| Nursing Intervention Group | Experimental | Participants received a structured nursing intervention program in addition to the usual outpatient care associated with ultrasound-guided foam sclerotherapy. The program included nursing assessment and education before the procedure, support during treatment, telephone follow-up on the following day, guidance on compression and self-care, access to telephone support, and scheduled follow-up. Receives: Other: Structured Nursing Intervention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Venous Clinical Severity Score at 6 Months
Clinical severity was assessed using the Venous Clinical Severity Score (VCSS). The scale consists of 10 clinical domains scored from 0 to 3, producing a total score ranging from 0 to 30. Higher scores indicate greater venous disease severity. A decrease from baseline indicates clinical improvement.
Measured: Baseline and 6 months after the procedure
Secondary outcomes (2)
Change From Baseline in CIVIQ-20 Score at 6 Months
Health-related quality of life was assessed using the 20-item Chronic Venous Insufficiency Questionnaire (CIVIQ-20), which evaluates pain, physical, psychological, and social dimensions. The global score is transformed to a scale from 0 to 100, with higher scores indicating better health-related quality of life. A positive change from baseline indicates improvement.
Measured: Baseline and 6 months after the procedure
Patient Satisfaction With Nursing Care Assessed Using the Baker Questionnaire
Patient satisfaction was assessed using the 13-item Baker Consultation Satisfaction Questionnaire. The questionnaire was administered only to participants in the nursing intervention group because it evaluated satisfaction with the structured nursing intervention program, which was not received by the usual care group. Items are rated on a 5-point Likert scale and evaluate three dimensions: professional care, professional relationship, and consultation time. Items were coded according to the questionnaire scoring method, and mean scores were calculated for each dimension. Higher scores indicate greater satisfaction after accounting for reverse-scored items.
Measured: At 6 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start9 Oct 2020
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Model description
- Two-arm parallel randomized controlled trial comparing a structured nursing intervention program plus usual care with usual care alone in patients undergoing ultrasound-guided foam sclerotherapy.
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Official College of Nurses of Barcelona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787065
- Sponsor's protocol ID
- PR(AG)133/2020
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eficacia de un Programa de intervención Enfermera Para Pacientes Sometidos a Escleroterapia de Vena Safena Interna
- ClinicalTrials.gov ID
- NCT07787065
- Acronym / sponsor ID
- PR(AG)133/2020
- Conditions
- Chronic Venous Disease
- Keywords
- Ultrasound-Guided Foam Sclerotherapy, Nursing Intervention, Advanced Practice Nursing, Venous Clinical Severity Score, Health-Related Quality of Life, CIVIQ-20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Official College of Nurses of Barcelona
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 26 Aug 2026 (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.
Chronic venous disease can cause pain, swelling, functional limitations, and reduced health-related quality of life. Ultrasound-guided foam sclerotherapy is commonly used to treat venous insufficiency. This randomized controlled trial evaluated whether a structured nursing intervention program, in addition to usual care, improved clinical severity and health-related quality of life in adults undergoing ultrasound-guided foam sclerotherapy at Vall d'Hebron University Hospital.
Participants were randomly assigned to usual care or to the nursing intervention program. The program included nursing assessment and education before the procedure, support during treatment, telephone follow-up on the following day, guidance on compression and self-care, access to telephone support, and scheduled follow-up. Clinical severity was assessed using the Venous Clinical Severity Score (VCSS), and health-related quality of life was evaluated using the Chronic Venous Insufficiency Questionnaire (CIVIQ-20). Satisfaction with care was also assessed in the intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel randomized controlled trial comparing a structured nursing intervention program plus usual care with usual care alone in patients undergoing ultrasound-guided foam sclerotherapy.
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | No intervention | –Participants received the usual outpatient care associated with ultrasound-guided foam sclerotherapy. They did not receive the structured nursing intervention program evaluated in this study. The sclerotherapy procedure was part of their clinically indicated treatment and was not assigned by the study. |
| Nursing Intervention Group | Experimental | Other: Structured Nursing Intervention ProgramParticipants received a structured nursing intervention program in addition to the usual outpatient care associated with ultrasound-guided foam sclerotherapy. The program included nursing assessment and education before the procedure, support during treatment, telephone follow-up on the following day, guidance on compression and self-care, access to telephone support, and scheduled follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with chronic venous insufficiency undergoing ultrasound-guided sclerotherapy, with or without active lower-extremity ulcers.
- Patients able to attend all scheduled sessions during the study period.
- Patients who provided written informed consent after receiving
Key exclusion criteria (3 listed)
- Patients who required hospital admission or discontinued participation during the study period.
- Patients who, because of neurological, psychological, or psychiatric conditions, were unable to continue attending the scheduled sessions.
- Accepts Healthy Volunteers: No Sex: All Gender Based: No Minimum Age: 18 Years Maximum Age: No Limit (N/A)
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 |
|---|---|---|
| Structured Nursing Intervention ProgramThe structured nursing intervention program was delivered in addition to usual care. It included a nursing consultation before the procedure with clinical assessment and individualized education; support during the sclerotherapy procedure; telephone follow-up on the following day; guidance on compression therapy, self-care, and warning signs; access to telephone support; and scheduled follow-up at three weeks and six months. Ultrasound-guided foam sclerotherapy was clinically indicated background treatment and was not assigned by the study. | Other | Nursing Intervention Group |
Primary outcome
Change From Baseline in Venous Clinical Severity Score at 6 Months
Time frame: Baseline and 6 months after the procedure
Clinical severity was assessed using the Venous Clinical Severity Score (VCSS). The scale consists of 10 clinical domains scored from 0 to 3, producing a total score ranging from 0 to 30. Higher scores indicate greater venous disease severity. A decrease from baseline indicates clinical improvement.
2 secondary outcomes
Change From Baseline in CIVIQ-20 Score at 6 Months
Time frame: Baseline and 6 months after the procedure
Patient Satisfaction With Nursing Care Assessed Using the Baker Questionnaire
Time frame: At 6 months after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Nursing Intervention Program in people with Chronic Venous Disease, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Venous Clinical Severity Score at 6 Months (time frame: Baseline and 6 months after the procedure). 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 26 Aug 2026.