Effect of Photobiomodulation on Healing of Venous Leg Ulcers
NCT07123285
Cardiovascular Diseases, Chronic Venous Disease
Lençóis Paulista, São Paulo, Brazil
View Trial DetailsNCT Number: NCT07737236
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Ankara Training and Research Hospital, Ankara, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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).
Time frame: Baseline, Day 30, and Day 90
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.
Time frame: Baseline, Day 30, and Day 90
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.
Time frame: Day 30 and Day 90
Treatment adherence will be assessed using the Visual Analog Scale for Adherence (VAS-U) during routine follow-up visits.
Time frame: Baseline to Day 90
Adverse events occurring during the observation period will be recorded and summarized according to severity, seriousness, and relationship to treatment.
Contact information is provided by the study sponsor or research team.
Turkish Society for Vascular and Endovascular Surgery
Other
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
Acronym: RESCUE-CVI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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