NCT07737236|Recruiting

Ruscus Evaluation for Symptom Control in Uncomplicated Chronic Venous Insufficiency

RESCUE-CVI

Evaluation of the Effects of Ruscus Aculeatus L. on Clinical Course and Quality of Life, and Assessment of Treatment Adherence and Tolerability in the Treatment of Chronic Venous Insufficiency: A Multicenter, Prospective, Observational Study

Turkish Society for Vascular and Endovascular Surgery ClinicalTrials.gov

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1 other identifier

NEOVPS02

Study Type

observational

Target

564

Locations

1 country

Sites

Timeline

RegisteredJul 2026

StartedJun 2026

CompletionJun 2027

Brief Summary

This multicenter, prospective, observational study aims to generate and analyze real-world data on the effectiveness and safety of Ruscus aculeatus L. treatment in patients with symptomatic chronic venous disease classified as CEAP C1-C6. Patients receiving Ruscus aculeatus L. as part of routine clinical practice will be followed for 90 days without any study-mandated intervention. Disease severity will be assessed using the revised Venous Clinical Severity Score (rVCSS), pain using the Visual Analog Scale (VAS), quality of life using the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20), treatment adherence using the Visual Analog Scale for adherence (VAS-U), and safety through the collection of adverse events during the observation period.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

564

participants targeted

Target at P75+ for all trials

Timeline

10mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach

1 country

25 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12 months study duration

Study Progress17%

Jun 2026Jun 2027

Study Start

First participant enrolled

June 2, 2026

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

July 27, 2026

Last Update Submit

July 30, 2026

Conditions

Chronic Venous Disease

Keywords

Chronic Venous DiseaseRuscus aculeatusCEAP ClassificationrVCSSCIVIQ-20

Outcome Measures

Primary Outcomes (2)

Change in revised Venous Clinical Severity Score (rVCSS)
Change in disease severity from baseline to Day 30 and Day 90 assessed using the revised Venous Clinical Severity Score (rVCSS). Higher scores indicate greater disease severity
Baseline, Day 30, and Day 90
Change in pain assessed by the Visual Analog Scale (VAS)
Change in pain severity at rest and during exercise from baseline to Day 30 and Day 90 assessed using the Visual Analog Scale (VAS), scored from 0 to 10. A score of 0 indicates no pain and a score of 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity.
Baseline, Day 30, and Day 90

Secondary Outcomes (4)

Change in Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score
Baseline, Day 30, and Day 90
Change in CEAP clinical class
Baseline, Day 30, and Day 90
Treatment adherence assessed by the Visual Analog Scale for Adherence (VAS-U)
Day 30 and Day 90
Incidence of adverse events
Baseline to Day 90

Study Arms (1)

Patients with Symptomatic Chronic Venous Disease Receiving Ruscus aculeatus L.

Adults with symptomatic chronic venous disease (CEAP C1-C6) who are prescribed Ruscus aculeatus L. as part of routine clinical practice. Participants will be followed prospectively for approximately 90 days without any study-specific intervention. Clinical outcomes, treatment adherence, quality of life, and safety data will be collected during routine clinical visits at baseline, Day 30, and Day 90.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Adults aged 18 to 75 years with symptomatic chronic venous disease (CEAP C1-C6) who are prescribed Ruscus aculeatus L. as part of routine clinical practice and provide written informed consent.

You may qualify if:

Adults aged 18 to 75 years.
Patients prescribed Ruscus aculeatus L. as part of routine clinical practice, with the baseline visit performed within 7 days after treatment initiation.
Symptomatic chronic venous disease classified as CEAP (2020) C1-C6.
Willing and able to provide written informed consent and complete study as sessments.

You may not qualify if:

Symptomatic patients classified as CEAP C0.
Uncontrolled hypertension.
Lower extremity dermatitis or ulcer related to peripheral arterial disease or diabetes.
Neurological or orthopedic conditions limiting mobility or independent walking.
Active systemic infection.
Known malignancy or ongoing chemotherapy.
Acute deep vein thrombosis or acute superficial vein thrombosis.
Cognitive or physical conditions preventing participation in routine follow-up visits.
Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Turkish Society for Vascular and Endovascular Surgerylead

Study Sites (25)

Ankara Training and Research Hospital

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

Ankara University Faculty of Medicine Hospital

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

Bilkent City Hospital

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

Etlik City Hospital

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

Gazi University Faculty of Medicine Hospital

Ankara, Ankara, Turkey (Türkiye)

NOT YET RECRUITING

SBU Gulhane Training and Research Hospital

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

SBU Sincan Training and Research Hospital

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

Yıldırım Beyazıt University Yenimahalle Training and Research Hospital

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

Gaziantep University Faculty of Medicine Hospital

Gaziantep, Gaziantep, Turkey (Türkiye)

NOT YET RECRUITING

Mustafa Kemal University Hospital

Antakya, Hatay, Turkey (Türkiye)

NOT YET RECRUITING

Bagcilar Training and Research Hospital