Chronic Venous Insufficiency, CVINCT07777978
Structured Home-Based Exercise and Education for Chronic Venous Insufficiency
A study testing Structured Home-Based Exercise and Education Program in people with Chronic Venous Insufficiency, CVI, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether a structured home-based exercise and education program can improve quality of life and leg symptoms in adults with chronic venous insufficiency. Chronic venous insufficiency occurs when the veins in the legs do not return blood effectively toward the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency, CVI
- What is being tested?
- Structured Home-Based Exercise and Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2026to 21 Sep 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Physician-confirmed diagnosis of chronic venous insufficiency
- CEAP clinical class C1-C4
- Ability to walk independently
- Ability to understand written and verbal instructions and participate in the group education and home-based exercise program
- Provision of written informed consent
- Symptomatic chronic venous disease affecting at least one lower limb
- Clinically stable and medically suitable for light-to-moderate exercise
Who cannot join
- Active or healed venous ulcer (CEAP clinical class C5 or C6)
- Acute deep vein thrombosis or active thromboembolic disease
- Lower-extremity surgery within the previous 3 months
- Severe peripheral arterial disease
- Uncontrolled cardiac, pulmonary, metabolic, or systemic disease
- Neurological, orthopedic, or vestibular disorder that prevents performance of the prescribed exercises or walking tests
Show all 12Show fewer
- Pregnancy
- Participation in another regular exercise or rehabilitation program during the study
- Severe cognitive, psychiatric, or communication disorder that could prevent adherence to the study protocol
- Active lower-extremity infection, cellulitis, or acute superficial vein thrombosis
- Coexisting lymphedema or lower-extremity edema primarily attributable to a non-venous cause
- Planned venous surgery, endovenous ablation, sclerotherapy, or another venous intervention during the 12-week study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bolu Abant Izzet Baysal University
Bolu, Bolu, 14030
Alp Özel, PhD, +903742534520 ext. 6155, alpozel@ibu.edu.tr
About this study
Official title: Effects of a Structured Home-Based Exercise and Education Program on Clinical and Functional Outcomes in Individuals With Chronic Venous Insufficiency: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether a structured home-based exercise and education program can improve quality of life and leg symptoms in adults with chronic venous insufficiency. Chronic venous insufficiency occurs when the veins in the legs do not return blood effectively toward the heart. The main questions the study aims to answer are: Does the exercise and education program improve quality of life related to chronic venous insufficiency after 8 weeks, and is any improvement maintained at Week 12? Does the program reduce leg symptoms after 8 weeks, and is any improvement maintained at Week 12? Researchers will compare participants who receive the structured exercise and education program in addition to standard medical care with participants who receive standard medical care and routine lifestyle advice without structured exercise training. A total of 120 participants will be assigned by chance to one of the two groups. Participants will: Continue the standard medical care recommended by their physicians. Attend assessments at the beginning of the study, at Week 8, and at Week 12. Complete questionnaires and tests assessing quality of life, leg symptoms, walking capacity, calf muscle endurance, physical activity, pain, heaviness, and lower-limb swelling. Participants assigned to the intervention group will also attend a 30- to 45-minute group education session, perform home-based exercises for 20 to 30 minutes per day on at least 5 days per week for 8 weeks, record their exercise sessions, and receive weekly follow-up by telephone or message.
Read the detailed description
The sample size was calculated using R version 4.5.3 with the pwr package. Previously published VEINES-QOL change data suggested a standardized effect size of approximately 0.72. However, because this estimate was derived from a single small study with very low-certainty evidence, a more conservative effect size of Cohen's d = 0.55 was prespecified. For a two-sided independent-samples comparison with a significance level of 0.05 and 80% statistical power, 53 participants were required in each group (106 participants in total). The target enrollment was increased to 120 participants to allow for potential attrition. The allocation sequence will be generated before participant enrollment by a staff nurse designated to manage the allocation process, using a prespecified script based on the blockrand package in R version 4.5.3, with a 1:1 allocation ratio and randomly varying block sizes. The designated staff nurse will otherwise not be involved in eligibility assessment, participant enrollment, intervention delivery, or outcome assessment. The sequence will be maintained in a password-protected electronic allocation system accessible only to the designated staff nurse. After eligibility has been confirmed, written informed consent has been obtained, and baseline assessments have been completed, the enrolling researcher will submit the participant's unique study identification number for allocation. The system will release only the assignment for the current participant, while future assignments will remain concealed. Repeated-measures data will be analyzed using linear mixed-effects models. Group, time, and the group-by-time interaction will be included as fixed effects, with participant-specific random effects included as appropriate. Statistical tests will be two-sided, with the significance level set at 0.05.
- Conditions
- Chronic Venous Insufficiency, CVI
- Being tested
- Structured Home-Based Exercise and Education Program, Standard Care (in control arm)
- Keywords
- Chronic Venous Disease, Home-Based Exercise, Exercise Therapy, Patient Education, Quality of Life, Venous Symptoms, Exercise Adherence
- Medical subject headings
- Blindness, Cortical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Home-Based Exercise and Education ProgramBehavioural
The intervention will be provided in addition to standard medical care. Participants will attend a 30- to 45-minute face-to-face group education and practical training session led by a physiotherapist. Education will cover chronic venous insufficiency, leg elevation, physical activity, weight management, lifestyle recommendations, and compression stocking use when prescribed. Participants will receive practical training in ankle pumping, plantar flexion and dorsiflexion, heel raises, calf muscle activation, walking, and light stretching. Correct exercise performance will be checked individually. Participants will perform the program at home for 20 to 30 minutes per day, at least 5 days per week, for 8 weeks. Adherence and potential adverse symptoms will be monitored weekly by telephone call or text message.
Standard Care (in control arm)Other
Standard care consists of physician-prescribed medical treatment and routine lifestyle recommendations for chronic venous insufficiency. Participants in the experimental arm will receive the structured home-based exercise and education program in addition to standard care.
| Study group | Role | What they receive |
|---|---|---|
| Structured Home-Based Exercise and Education Group | Experimental | Participants in this arm will continue their physician-prescribed standard medical treatment and receive a structured exercise and education program. The program will begin with a 30- to 45-minute face-to-face group session led by a physiotherapist. The session will include education about chronic venous insufficiency, leg elevation, physical activity, weight management, lifestyle recommendations, and compression stocking use when recommended by a physician. Participants will also receive instruction and supervised practice in ankle pumping, plantar flexion and dorsiflexion, heel raises, calf muscle activation, walking, and light stretching exercises. They will perform the exercise program at home for 20 to 30 minutes per day on at least 5 days per week for 8 weeks. Adherence and potential adverse symptoms will be monitored weekly by telephone call or text message and documented using a daily exercise log. Receives: Behavioral: Structured Home-Based Exercise and Education Program |
| Control Group | Active comparator | Participants assigned to this arm will continue their physician-prescribed standard medical treatment and receive routine lifestyle recommendations for the management of chronic venous insufficiency. They will not receive the structured group education session, study-specific home-based exercise program, or weekly adherence monitoring provided to the experimental group. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VEINES-QOL Score
VEINES-QOL is the 25-item quality-of-life summary score derived from the 26-item VEINES-QOL/Sym questionnaire. It assesses the impact of chronic venous disease on symptoms, daily activities, and psychological well-being during the previous 4 weeks. Scores will be transformed to a 0-100 scale, with higher scores indicating better disease-specific quality of life. Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate improvement.
Measured: Baseline, Week 8, and Week 12
Change in VEINES-Sym Score
VEINES-Sym is the 10-item symptom summary score derived from the 26-item VEINES-QOL/Sym questionnaire. It assesses the frequency and severity of venous disease-related symptoms during the previous 4 weeks. Scores will be transformed to a 0-100 scale, with higher scores indicating fewer or less severe symptoms. Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate symptom improvement.
Measured: Baseline, Week 8, and Week 12
Secondary outcomes (7)
Change in Six-Minute Walk Distance
The Six-Minute Walk Test will be used to assess submaximal functional exercise capacity. Participants will be instructed to walk as far as possible for 6 minutes along a flat corridor of at least 30 meters. The total distance walked will be recorded in meters. Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate improvement in functional exercise capacity.
Measured: Baseline, Week 8, and Week 12
Change in Heel Rise Test Repetitions
The Heel Rise Test will be used to assess calf muscle endurance and plantar flexor function. Participants will stand on one leg and perform as many heel-rise repetitions as possible according to a standardized protocol. The number of correctly completed repetitions will be recorded, and the same lower extremity will be assessed at each visit. Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate improvement in calf muscle endurance.
Measured: Baseline, Week 8, and Week 12
Change in IPAQ-SF Total Physical Activity
The International Physical Activity Questionnaire-Short Form (IPAQ-SF) is a 7-item self-report questionnaire that assesses physical activity performed during the previous 7 days. The reported frequency and duration of walking, moderate-intensity activity, and vigorous-intensity activity will be used to calculate total physical activity in metabolic equivalent minutes per week (MET-min/week) according to the IPAQ scoring protocol. Higher values indicate a greater level of physical activity. Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate increased physical activity.
Measured: Baseline, Week 8, and Week 12
Change in Pain Intensity
Lower-extremity pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with anchors of 0 mm indicating no pain and 100 mm indicating the most severe pain. Higher scores indicate greater pain intensity. Change from baseline will be evaluated at Weeks 8 and 12; a reduction in the score indicates improvement.
Measured: Baseline, Week 8, and Week 12
Change in Lower-Extremity Heaviness
Perceived lower-extremity heaviness will be assessed using a 100-mm Visual Analog Scale (VAS), with anchors of 0 mm indicating no heaviness and 100 mm indicating the most severe heaviness. Higher scores indicate greater symptom severity. Change from baseline will be evaluated at Weeks 8 and 12; a reduction in the score indicates improvement.
Measured: Baseline, Week 8, and Week 12
Change in Lower-Extremity Volume
Lower-extremity volume will be estimated from serial circumference measurements using the truncated-cone method. The index limb will be selected before randomization: the affected limb in unilateral disease, the limb with the higher CEAP class in bilateral disease, or the right limb if CEAP classes are equal. With the participant standing, circumferences will be measured using a non-elastic tape from 4 cm above the floor proximally at 4-cm intervals to just below the knee joint line. If the final interval is shorter than 4 cm, its actual length will be used. Segment volumes will be calculated and summed to obtain total volume in milliliters. The same limb and measurement levels will be used at all visits. Higher values indicate greater edema. Change from baseline will be assessed at Weeks 8 and 12; a reduction indicates improvement.
Measured: Baseline, Week 8, and Week 12
Exercise Adherence Rate
Exercise adherence will be assessed in the experimental group using daily exercise logs reviewed during weekly telephone calls or text-message follow-ups. An exercise day will be considered completed when the participant reports performing the prescribed home-based program for at least 20 minutes. The adherence rate will be calculated as the number of completed exercise days divided by 40 prescribed exercise days (5 days per week for 8 weeks), multiplied by 100. Values will range from 0% to 100%, with higher percentages indicating greater adherence.
Measured: Throughout the 8-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start28 Aug 2026
- Primary completion21 Sep 2027 (estimated)
- Study completion21 Sep 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 Insufficiency, CVIStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group randomized controlled trial with a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Ozel, Abant Izzet Baysal University
- Investigators
- Alp Özel, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777978
- Sponsor's protocol ID
- AIBU-FTR-AO-06
- Other IDs
- 2026-SOS-05
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the primary publication will be shared. These data will include demographic and baseline clinical characteristics, allocated study group, VEINES-QOL and VEINES-Sym scores, Six-Minute Walk Test distance, Heel Rise Test repetitions, IPAQ-SF total physical activity, pain and lower-extremity heaviness scores, lower-extremity volume, exercise adherence, adverse events, withdrawal status, and outcome data collected at the relevant study time points. A data dictionary and coding guide will accompany the dataset. Direct identifiers and free-text information that could permit participant re-identification will not be shared. Only data from participants whose consent permits data sharing will be included.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Structured Home-Based Exercise and Education Program on Clinical and Functional Outcomes in Individuals With Chronic Venous Insufficiency: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07777978
- Acronym / sponsor ID
- AIBU-FTR-AO-06
- Conditions
- Chronic Venous Insufficiency, CVI
- Keywords
- Chronic Venous Disease, Home-Based Exercise, Exercise Therapy, Patient Education, Quality of Life, Venous Symptoms, Exercise Adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 21 Sep 2027 (estimated)
- Study completion
- 21 Sep 2027 (estimated)
- First posted
- 21 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.
The goal of this clinical trial is to learn whether a structured home-based exercise and education program can improve quality of life and leg symptoms in adults with chronic venous insufficiency. Chronic venous insufficiency occurs when the veins in the legs do not return blood effectively toward the heart. The main questions the study aims to answer are: Does the exercise and education program improve quality of life related to chronic venous insufficiency after 8 weeks, and is any improvement maintained at Week 12? Does the program reduce leg symptoms after 8 weeks, and is any improvement maintained at Week 12? Researchers will compare participants who receive the structured exercise and education program in addition to standard medical care with participants who receive standard medical care and routine lifestyle advice without structured exercise training. A total of 120 participants will be assigned by chance to one of the two groups. Participants will: Continue the standard medical care recommended by their physicians. Attend assessments at the beginning of the study, at Week 8, and at Week 12. Complete questionnaires and tests assessing quality of life, leg symptoms, walking capacity, calf muscle endurance, physical activity, pain, heaviness, and lower-limb swelling. Participants assigned to the intervention group will also attend a 30- to 45-minute group education session, perform home-based exercises for 20 to 30 minutes per day on at least 5 days per week for 8 weeks, record their exercise sessions, and receive weekly follow-up by telephone or message.
Detailed description
The sample size was calculated using R version 4.5.3 with the pwr package. Previously published VEINES-QOL change data suggested a standardized effect size of approximately 0.72. However, because this estimate was derived from a single small study with very low-certainty evidence, a more conservative effect size of Cohen's d = 0.55 was prespecified. For a two-sided independent-samples comparison with a significance level of 0.05 and 80% statistical power, 53 participants were required in each group (106 participants in total). The target enrollment was increased to 120 participants to allow for potential attrition. The allocation sequence will be generated before participant enrollment by a staff nurse designated to manage the allocation process, using a prespecified script based on the blockrand package in R version 4.5.3, with a 1:1 allocation ratio and randomly varying block sizes. The designated staff nurse will otherwise not be involved in eligibility assessment, participant enrollment, intervention delivery, or outcome assessment. The sequence will be maintained in a password-protected electronic allocation system accessible only to the designated staff nurse. After eligibility has been confirmed, written informed consent has been obtained, and baseline assessments have been completed, the enrolling researcher will submit the participant's unique study identification number for allocation. The system will release only the assignment for the current participant, while future assignments will remain concealed. Repeated-measures data will be analyzed using linear mixed-effects models. Group, time, and the group-by-time interaction will be included as fixed effects, with participant-specific random effects included as appropriate. Statistical tests will be two-sided, with the significance level set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled trial with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Structured Home-Based Exercise and Education Group | Experimental | Behavioral: Structured Home-Based Exercise and Education ProgramParticipants in this arm will continue their physician-prescribed standard medical treatment and receive a structured exercise and education program. The program will begin with a 30- to 45-minute face-to-face group session led by a physiotherapist. The session will include education about chronic venous insufficiency, leg elevation, physical activity, weight management, lifestyle recommendations, and compression stocking use when recommended by a physician. Participants will also receive instruction and supervised practice in ankle pumping, plantar flexion and dorsiflexion, heel raises, calf muscle activation, walking, and light stretching exercises. They will perform the exercise program at home for 20 to 30 minutes per day on at least 5 days per week for 8 weeks. Adherence and potential adverse symptoms will be monitored weekly by telephone call or text message and documented using a daily exercise log. |
| Control Group | Active comparator | Other: Standard Care (in control arm)Participants assigned to this arm will continue their physician-prescribed standard medical treatment and receive routine lifestyle recommendations for the management of chronic venous insufficiency. They will not receive the structured group education session, study-specific home-based exercise program, or weekly adherence monitoring provided to the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 years or older
- Physician-confirmed diagnosis of chronic venous insufficiency
- CEAP clinical class C1-C4
- Ability to walk independently
- Ability to understand written and verbal instructions and participate in the group education and home-based exercise program
Key exclusion criteria (12 listed)
- Active or healed venous ulcer (CEAP clinical class C5 or C6)
- Acute deep vein thrombosis or active thromboembolic disease
- Lower-extremity surgery within the previous 3 months
- Severe peripheral arterial disease
- Uncontrolled cardiac, pulmonary, metabolic, or systemic disease
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 Home-Based Exercise and Education ProgramThe intervention will be provided in addition to standard medical care. Participants will attend a 30- to 45-minute face-to-face group education and practical training session led by a physiotherapist. Education will cover chronic venous insufficiency, leg elevation, physical activity, weight management, lifestyle recommendations, and compression stocking use when prescribed. Participants will receive practical training in ankle pumping, plantar flexion and dorsiflexion, heel raises, calf muscle activation, walking, and light stretching. Correct exercise performance will be checked individually. Participants will perform the program at home for 20 to 30 minutes per day, at least 5 days per week, for 8 weeks. Adherence and potential adverse symptoms will be monitored weekly by telephone call or text message. | Behavioural | Structured Home-Based Exercise and Education Group |
| Standard Care (in control arm)Standard care consists of physician-prescribed medical treatment and routine lifestyle recommendations for chronic venous insufficiency. Participants in the experimental arm will receive the structured home-based exercise and education program in addition to standard care. | Other | Control Group |
Primary outcome
Change in VEINES-QOL Score
Time frame: Baseline, Week 8, and Week 12
VEINES-QOL is the 25-item quality-of-life summary score derived from the 26-item VEINES-QOL/Sym questionnaire. It assesses the impact of chronic venous disease on symptoms, daily activities, and psychological well-being during the previous 4 weeks. Scores will be transformed to a 0-100 scale, with higher scores indicating better disease-specific quality of life. Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate improvement.
Change in VEINES-Sym Score
Time frame: Baseline, Week 8, and Week 12
VEINES-Sym is the 10-item symptom summary score derived from the 26-item VEINES-QOL/Sym questionnaire. It assesses the frequency and severity of venous disease-related symptoms during the previous 4 weeks. Scores will be transformed to a 0-100 scale, with higher scores indicating fewer or less severe symptoms. Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate symptom improvement.
7 secondary outcomes
Change in Six-Minute Walk Distance
Time frame: Baseline, Week 8, and Week 12
Change in Heel Rise Test Repetitions
Time frame: Baseline, Week 8, and Week 12
Change in IPAQ-SF Total Physical Activity
Time frame: Baseline, Week 8, and Week 12
Change in Pain Intensity
Time frame: Baseline, Week 8, and Week 12
Change in Lower-Extremity Heaviness
Time frame: Baseline, Week 8, and Week 12
Change in Lower-Extremity Volume
Time frame: Baseline, Week 8, and Week 12
Exercise Adherence Rate
Time frame: Throughout the 8-week intervention period.
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 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the primary publication will be shared. These data will include demographic and baseline clinical characteristics, allocated study group, VEINES-QOL and VEINES-Sym scores, Six-Minute Walk Test distance, Heel Rise Test repetitions, IPAQ-SF total physical activity, pain and lower-extremity heaviness scores, lower-extremity volume, exercise adherence, adverse events, withdrawal status, and outcome data collected at the relevant study time points. A data dictionary and coding guide will accompany the dataset. Direct identifiers and free-text information that could permit participant re-identification will not be shared. Only data from participants whose consent permits data sharing will be included.
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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.
Alp Özel, PhD principal investigator
Abant Izzet Baysal University
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 Home-Based Exercise and Education Program in people with Chronic Venous Insufficiency, CVI, run by Abant Izzet Baysal University at 1 site 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 8 inclusion and 12 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 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 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 Alp Özel, PhD (+903742534520 ext. 6155, alpozel@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VEINES-QOL Score (time frame: Baseline, Week 8, and Week 12). 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 Aug 2026.