Chronic Venous DiseaseRESCUE-CVINCT07737236
Ruscus Evaluation for Symptom Control in Uncomplicated Chronic Venous Insufficiency
An observational study of Chronic Venous Disease, run by Turkish Society for Vascular and Endovascular Surgery at 25 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Venous Disease
- How many people
- 564 participants
- Where
- 25 sitesTurkey (Türkiye)
- Study dates
- 2 Jun 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Acute deep vein thrombosis or acute superficial vein thrombosis.
- Cognitive or physical conditions preventing participation in routine follow-up visits.
- Pregnant or breastfeeding women.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
Turkey (Türkiye)25 sites, 25 recruiting
- Recruiting
Ankara Training and Research Hospital
Ankara, Ankara
Ali Cemal Düzgün, MD, +90 532 477 43 31, drcemalduzgun@gmail.com
Ali Cemal Düzgün, MD
- Recruiting
Ankara University Faculty of Medicine Hospital
Ankara, Ankara
Evren Özçınar, MD, +90 532 622 96 72, evrenozcınar@gmail.com
Evren Özçınar, MD
- Recruiting
Bilkent City Hospital
Ankara, Ankara
Kemal Eşref Erdoğan, MD, +90 555 300 53 35, kemal_esref@hotmail.com
Kemal Eşref Erdoğan, MD
- Recruiting
Etlik City Hospital
Ankara, Ankara
İlker İnce, MD, +90 505 589 43 39, ilkerince78@hotmail.com
İlker İnce, MD
- Not yet recruiting
Gazi University Faculty of Medicine Hospital
Ankara, Ankara
Abdullah Özer, MD, +90 505 223 13 95, dr-abdozer@hotmail.com
Abdullah Özer, MD
- Recruiting
SBU Gulhane Training and Research Hospital
Ankara, Ankara
Gökhan Arslan, MD, +90 532 736 80 19, drgokhanarslan@gmail.com
Gökhan Arslan, MD
- Recruiting
SBU Sincan Training and Research Hospital
Ankara, Ankara
Tarık Taştekin, MD, +90 505 468 04 56, tariktastekin@gmail.com
Tarık Taştekin, MD
- Recruiting
Yıldırım Beyazıt University Yenimahalle Training and Research Hospital
Ankara, Ankara
Mehmet Burak Gülcan, MD, +90 533 960 73 69, drmburakgulcan@gmail.com
Mehmet Burak Gülcan, MD
- Not yet recruiting
Mustafa Kemal University Hospital
Antakya, Hatay
Sefer Kaya, MD, +90 506 370 12 50, drseferkaya@hotmail.com
Sefer Kaya, MD
- Recruiting
Antalya City Hospital
Antalya
Nevzat Erdil, MD, +90 532 427 18 20, nevzatkutay@gmail.com
Nevzat Erdil, MD
- Not yet recruiting
Gaziantep University Faculty of Medicine Hospital
Gaziantep, Gaziantep
Gökalp Güzel, MD, +90 532 703 35 06, drgokalpguzel@gmail.com
gökalp Güzel, MD
- Recruiting
Bagcilar Training and Research Hospital
Istanbul, Istanbul
Adil Polat, MD, +90 532 230 24 75, dradilpolat@gmail.com
Adil Polat, MD
- Recruiting
Bahcelievler State Hospital
Istanbul, Istanbul
Mehmet Atay, MD, +90 542 723 61 11, drataym@gmail.com
Mehmet Atay, MD
- Not yet recruiting
Bakırköy Sadi Konuk Eğitim Araştırma Hastanesi
Istanbul, Istanbul
Helin El Kılıç, MD, +90 505 655 07 26, helin_el@hotmail.com
Helin El Kılıç, MD
- Recruiting
Bezmiâlem Foundation University Hospital
Istanbul, Istanbul
Ünal Aydın, MD, +90 532 350 76 22, unalaydin41@gmail.com
Ünal Aydın, MD
- Recruiting
Kartal Dr. Lütfi Kırdar City Hospital
Istanbul, Istanbul
Sinem Yiğt Uğur, MD, +90 505 729 28 02, sinemyigit3@gmail.com
Sinem Yiğit Uğur, MD
- Recruiting
Koşuyolu High Specialization Training and Research Hospital
Istanbul, Istanbul
Murat Rabuş, MD, +90 505 237 99 57, 'muratbulent.rabus@sbu.edu.tr'
Murat Rabuş, MD
- Not yet recruiting
Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul, Istanbul
Serkan Ketenciler, MD, +90 532 622 75 60, ketencilers@hotmail.com
Serkan Ketenciler, MD
- Recruiting
SBÜ Şişli Hamidiye Etfal Training and Research Hospital
Istanbul, Istanbul
Hale Bogi Demir, MD, +90 535 563 66 09, hbolgi@yahoo.com
Hale Bogi Demir, MD
- Recruiting
Bakırçay Üniversitesi Çiğli Eğitim ve Araştırma Hastanesi
Izmir, İzmir
Şahin Bozok, MD, +90 533 236 24 42, sahinboz@yahoo.com
Şahin Bozok, MD
- Recruiting
Ege University Faculty of Medicine Hospital
Izmir, İzmir
Emrah Oğuz, MD, +90 535 896 90 35, emroguz@hotmail.com
Emrah Oğuz, MD
- Recruiting
Kahramanmaraş Sütçü İmam University Faculty of Medicine
Kahramanmaraş, Kahramanmaraş
Mehmet Kirişçi, MD, +90 505 718 18 98, drkirisci@yahoo.com
Mehmet Kirişçi, MD
- Recruiting
Necmettin Erbakan University Meram Faculty of Medicine Hospital
Konya, Konya
Ömer Tanyeli, MD, +90 532 767 89 09, otanyeli@gmail.com
Ömer Tanyeli, MD
- Recruiting
Inonu University Turgut Ozal Medical Center
Malatya, Malatya
Barış Akça, MD, +90 505 697 46 80, baris.akca@inonu.edu.tr
Barış Akça, MD
- Recruiting
Sivas Cumhuriyet University Faculty of Medicine Research and Application Hospital
Sivas, Sivas
Yusuf Taşpınar, MD, +90 538 367 95 84, tpinaryusuf@gmail.com
Yusuf Taşpınar, MD
About this study
Official title: 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
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.
Read the detailed description
Chronic venous disease (CVD) is a common condition associated with considerable morbidity and reduced quality of life. Ruscus aculeatus L. has been used as a venoactive agent for the symptomatic treatment of chronic venous disease; however, real-world clinical data on the use of Ruscus aculeatus L. alone remain limited.
This multicenter, prospective, observational study is designed to generate real-world evidence on the effectiveness, safety, treatment adherence, and quality of life associated with Ruscus aculeatus L. treatment in patients with symptomatic chronic venous disease classified as CEAP C1-C6. Patients who are prescribed Ruscus aculeatus L. as part of routine clinical practice will be followed for approximately 90 days without any study-specific intervention. Treatment decisions, diagnostic procedures, and patient management will remain entirely at the discretion of the treating physician.
Clinical outcomes will be evaluated using the revised Venous Clinical Severity Score (rVCSS), pain assessed by the Visual Analog Scale (VAS), quality of life assessed by the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20), treatment adherence assessed by the Visual Analog Scale for adherence (VAS-U), and safety assessed through the collection of adverse events during routine follow-up visits. Data will be collected during routine clinical visits at baseline, Day 30, and Day 90.
- Conditions
- Chronic Venous Disease
- Keywords
- Chronic Venous Disease, Ruscus aculeatus, CEAP Classification, rVCSS, CIVIQ-20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline, Day 30, and Day 90
Secondary outcomes (4)
Change in Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score
Change in quality of life from baseline to Day 30 and Day 90 assessed using the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20). Higher scores indicate better quality of life.
Measured: Baseline, Day 30, and Day 90
Change in CEAP clinical class
Change in CEAP clinical class from baseline to Day 30 and Day 90 will be recorded descriptively to evaluate the clinical course of chronic venous disease.
Measured: Baseline, Day 30, and Day 90
Treatment adherence assessed by the Visual Analog Scale for Adherence (VAS-U)
Treatment adherence will be assessed using the Visual Analog Scale for Adherence (VAS-U), a self-reported 100-mm visual analog scale ranging from 0 to 100 mm. A score of 0 mm indicates "never" taking the medication as prescribed, and a score of 100 mm indicates "always" taking the medication as prescribed. Higher scores indicate better treatment adherence.
Measured: Day 30 and Day 90
Incidence of adverse events
Adverse events occurring during the observation period will be recorded and summarized according to severity, seriousness, and relationship to treatment.
Measured: Baseline to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start2 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish Society for Vascular and Endovascular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nevzate Erdil, MD, Principal investigator, Antalya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737236
- Sponsor's protocol ID
- NEOVPS02
- Acronym
- RESCUE-CVI
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) collected during this study will not be shared with other researchers. No plan has been established for sharing de-identified individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07737236
- Acronym / sponsor ID
- RESCUE-CVI / NEOVPS02
- Conditions
- Chronic Venous Disease
- Keywords
- Chronic Venous Disease, Ruscus aculeatus, CEAP Classification, rVCSS, CIVIQ-20
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Turkish Society for Vascular and Endovascular SurgeryUniversity, hospital or other
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 30 Jul 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.
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.
Detailed description
Chronic venous disease (CVD) is a common condition associated with considerable morbidity and reduced quality of life. Ruscus aculeatus L. has been used as a venoactive agent for the symptomatic treatment of chronic venous disease; however, real-world clinical data on the use of Ruscus aculeatus L. alone remain limited.
This multicenter, prospective, observational study is designed to generate real-world evidence on the effectiveness, safety, treatment adherence, and quality of life associated with Ruscus aculeatus L. treatment in patients with symptomatic chronic venous disease classified as CEAP C1-C6. Patients who are prescribed Ruscus aculeatus L. as part of routine clinical practice will be followed for approximately 90 days without any study-specific intervention. Treatment decisions, diagnostic procedures, and patient management will remain entirely at the discretion of the treating physician.
Clinical outcomes will be evaluated using the revised Venous Clinical Severity Score (rVCSS), pain assessed by the Visual Analog Scale (VAS), quality of life assessed by the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20), treatment adherence assessed by the Visual Analog Scale for adherence (VAS-U), and safety assessed through the collection of adverse events during routine follow-up visits. Data will be collected during routine clinical visits at baseline, Day 30, and Day 90.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in revised Venous Clinical Severity Score (rVCSS)
Time frame: Baseline, Day 30, and Day 90
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
Change in pain assessed by the Visual Analog Scale (VAS)
Time frame: Baseline, Day 30, and Day 90
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.
4 secondary outcomes
Change in Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score
Time frame: Baseline, Day 30, and Day 90
Change in CEAP clinical class
Time frame: Baseline, Day 30, and Day 90
Treatment adherence assessed by the Visual Analog Scale for Adherence (VAS-U)
Time frame: Day 30 and Day 90
Incidence of adverse events
Time frame: Baseline to Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) collected during this study will not be shared with other researchers. No plan has been established for sharing de-identified individual participant data.
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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.
Nevzate Erdil, MD principal investigator
Antalya City Hospital
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Disease, run by Turkish Society for Vascular and Endovascular Surgery at 25 sites in Turkey (Türkiye).
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 9 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nevzat Erdil, MD (+90 532 427 18 20, nevzatkutay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in revised Venous Clinical Severity Score (rVCSS) (time frame: Baseline, Day 30, and Day 90). The study lists 2 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 31 Jul 2026.