Chronic Venous Insufficiency, CVINCT06785805
Respiratory Functions, Aerobic Capacity and Quality of Life in Chronic Venous Insufficiency
An observational study of Chronic Venous Insufficiency, CVI, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to retrospectively examine the dataset obtained from a previously conducted study titled 'Inspiratory muscle training in individuals with chronic venous insufficiency: randomized controlled trial'. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Venous Insufficiency, CVI
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2023to 24 Jun 2024
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals diagnosed with chronic venous insufficiency volunteered to participate in the study
Who may be able to join
- Being diagnosed with chronic venous insufficiency
- Agreeing to participate in the study
- Being 18 years of age or older
Who cannot join
- Presence of arterial diseases
- Presence of advanced cardiorespiratory diseases
- Presence of acute ulcers (< 3 months) and diabetic ulcers
- Being pregnant
- Presence of deep vein thrombosis
- Presence of active infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Democracy University
Izmir, Karabağlar/İzmir, 35140
About this study
Official title: Relationship Between Disease Severity, Pain, Lower Extremity Strength, Respiratory Functions, Aerobic Capacity and Quality of Life in Individuals With Chronic Venous Insufficiency
This study aims to retrospectively examine the dataset obtained from a previously conducted study titled 'Inspiratory muscle training in individuals with chronic venous insufficiency: randomized controlled trial'. The previously conducted study was a study investigating the effectiveness of the application, and the current study aims to clarify the gap in the literature with the relationship between the data obtained from the patients at the beginning of that study. This study will be conducted by re-examining the initial data of another study from which data was collected before and conducting new analyses.
H0: There is no relationship between disease severity, edema, pain, respiratory muscle strength, respiratory functions, aerobic capacity, lower extremity strength or quality of life in individuals with chronic venous insufficiency.
H1: There is a relationship between disease severity, edema, pain, respiratory muscle strength, respiratory functions, aerobic capacity, lower extremity strength or quality of life in individuals with chronic venous insufficiency.
Read the detailed description
Chronic Venous Insufficiency (CVI) is a term used to describe a disorder that affects the venous system of the lower extremities and results in venous hypertension. Venous pathology develops when venous pressure increases and the return of blood is impaired by various mechanisms. These pathologies are caused by valve insufficiency, venous obstruction or inadequate functioning of the muscle pump. The veins in the calf and the tissues surrounding them form the muscle pump. The muscle pump is responsible for venous blood circulation and is activated by ankle movements. In venous insufficiency, one-way valves and vein walls relax, resulting in muscle pump dysfunction. CVI can cause various pathologies and subjective symptoms such as leg pain and cramps, a feeling of heaviness, edema and skin changes. All these symptoms negatively affect the quality of life depending on the intensity of pain, severity of edema and the presence of inflammation. In CVI, the limitation of ankle movement is one of the factors that increase edema and venous severity. Fibrotic tissue formations in the lower extremity cause limitation in ankle movements. It should not be forgotten that functionality and quality of life are closely related phenomena, as the physical activity levels and functional capacity deterioration of people with chronic venous insufficiency increase, the quality of life decreases, which further worsens the prognosis of the disease. Complications of CVI impair the person's ability to participate in social or routine occupational activities, reduce working capacity, and ultimately increase the economic burden on the person and the family. Chronic venous diseases are a common condition that causes great socioeconomic effects due to their high prevalence. 32% of women and 40% of men have varicose veins. In addition, any type of venous disease affects 40-50% of men and 50-55% of women. CVI risk factors include heredity, pregnancy, aging, thrombosis, connective tissue laxity, inactivity, excessive weight, use of high-heeled shoes, standing for long periods, wearing tight clothes, being a woman, geographical effects and improper eating habits. Diagnosis of chronic venous disease is based on anamnesis, clinical symptoms and diagnostic tests. Today, duplex ultrasound is the gold standard for the diagnosis of CVI. The most widely used classification system for the classification of CVI is the CEAP classification system, which includes clinical, etiological, anatomical and pathophysiological effects and stages. In this classification, CEAP stands for; C: Clinical appearance, E: Etiological factors, A: Anatomical distribution, P: Pathophysiological condition. In general, C (clinical features)-classification is used in daily clinical practice. Insufficiency of the muscle pump includes not only calf muscle insufficiency but also respiratory muscle insufficiency. The diaphragm is a dome-shaped musculofibrous layer that separates the thorax and abdomen. The diaphragm, which acts as the main inspiratory muscle, creates a suction effect on the inferior vena cava during inspiration and expiration, allowing more blood flow from the lower extremities to the heart. Changes in pressure in the thoraco-abdominal region directly affect venous flow. Inspiration increases negative intrathoracic pressure, causing blood to be sucked into the thorax. Simultaneously, the diaphragm contracts and the abdominal veins are compressed. These changes in intrathoracic and intraabdominal pressures that occur with respiration help venous return by preventing retrograde flow in the veins. It has been shown that the respiratory cycle affects venous return in healthy individuals, and that the flow rate in the femoral vein increases with deep inspiration. However, no study has been found examining the relationship between disease severity, edema, pain, respiratory muscle strength, respiratory functions, aerobic capacity, lower extremity strength and quality of life in individuals with chronic venous insufficiency. For this reason, since the relationship between disease severity, disease symptoms, respiratory functions, aerobic capacity and quality of life in individuals with chronic venous insufficiency is unknown, this study aimed to clarify it.
- Conditions
- Chronic Venous Insufficiency, CVI
- Keywords
- disease severity, chronic venous insufficiency, respiratory functions
- Medical subject headings
- Blindness, Cortical
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 |
|---|---|---|
| Individuals with Chronic venous insufficiency | Our prospective randomized controlled planned study named 'Inspiratory Muscle Training in Individuals with Chronic Venous Insufficiency: Randomized Controlled Study', which was approved by Izmir Democracy University Non-Interventional Clinical Research Ethics Committee on 21/06/2023 with the decision number 2023/08-02, was conducted. Although 38 individuals diagnosed with CVI were included in the study, the study was completed with 30 individuals diagnosed with CVI who could complete the 6-week follow-up. In the current study, which is a continuation of the previsious research; It is aimed to analyze the initial measurement results of 38 individuals diagnosed with CVI who were initially included in the study and to contribute these data to the literature with a retrospective cross-sectional study design. Our new hypothesis is based on the examination of the correlation between these initial outcome measurements obtained from our previous study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease severity
The disease severity (CEAP scores) of the individuals referred to the study were determined by the cardiovascular surgeon.
Measured: From July 2023 to May 2024
Secondary outcomes (7)
Evaluation of Lower Extremity Strength
The 30-second Sit-to-Stand Test was used on a chair to determine lower extremity strength and functional mobility. Rikli et al. designed a 30-second sit-to-stand test in 1999 to evaluate individuals' dynamic balance and physical fitness lower extremity neuromuscular function levels. During the test, the individual sat on a chair without back support, arms crossed over the body, which was the initial sitting position. Then, the individual stood up and sat down repeatedly for 30 seconds. The total number of correct standing ups during this period was recorded. A higher number of repetitions indicates better physical performance. Performing less than 10 repetitions of the movement in 30 seconds indicates lower extremity weakness.
Measured: From July 2023 to May 2024
Assessment of aerobic capacity
The 6-minute walking test was performed according to ATS criteria and twice on the same day, half an hour apart. Before the test, the subjects rested for at least 10 minutes, and before and after the test, oxygen saturation, heart rate, blood pressure, respiratory rate, dyspnea perception, fatigue and leg fatigue were recorded. Oxygen saturation was assessed using a portable pulse oximeter, heart rate using a heart rate monitor, blood pressure using a sphygmomanometer, respiratory rate using a count of the breaths taken per minute, and fatigue, leg fatigue and dyspnea perception using the Modified Borg Scale. The starting and ending points in the corridor where the test would be performed were determined and marked with cones. The subjects were asked to walk as fast as they could at their own walking speed for 6 minutes on a 30-meter straight corridor. In order to encourage the subjects, standard expressions were used for each minute during the test and the 6-MWT distance was recorded
Measured: From July 2023 to May 2024
Evaluation of respiratory functions
A spirometer was used to evaluate respiratory functions. Before the test, individuals rested for 15 minutes and during the rest, participants were told how to do the test, how to use a mouthpiece, when to inhale and exhale, and how to complete the test with maximum effort, and then they were shown a practical demonstration. While individuals were sitting in a comfortable position in a chair with a back, a clip was placed on their noses and they were asked to bite the mouthpiece with their teeth and close their lips so that they would not allow air to escape. During the test, individuals were asked to exhale until there was no air left in their lungs and they were allowed to follow the time on the monitor. The tests were to be performed by the participants at least 3 times and it was ensured that the expiration time was at least 6 seconds and the plateau time was 1 second.
Measured: From July 2023 to May 2024
Respiratory muscle strength assessment
Respiratory muscle strength was assessed with a spirometer. The pressure was recorded during a few seconds of maximal inspiration (Müller maneuver) or expiration (Valsalva maneuver) through the mouth. Maximum static inspiratory pressure was measured by having the patients take a rapid and deep inspiration at the residual volume after maximum expiration. Maximum static expiratory pressure was measured by having the patients take a rapid and deep expiration at the total lung capacity after maximum inspiration. The tests were performed in the sitting position using a nose clip. The patients were verbally encouraged to achieve the best strength. The measurement was repeated until a valid value was obtained in the patients. If there was a difference of more than 5% or 5 cmH₂O between the consecutive measured values, the measurement was repeated.
Measured: From July 2023 to May 2024
Quality of life assessment
The Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ) was used to assess quality of life. The questionnaire consists of 20 questions specific to Chronic Venous Insufficiency. It consists of 4 parameters questioning physical, psychological, social status and pain. Each question is scored according to a 5-item Likert scale. Higher scores indicate better quality of life. The Turkish validity and reliability study was conducted by Özdemir et al.
Measured: From July 2023 to May 2024
Pain Assessment
Pain intensity was measured with the Numerical Rating Scale (SDS). The maximum level of pain felt at rest and during activity was scored from 0 to 10. A value of "0" indicates no pain, and a value of "10" indicates pain of the worst intensity. The reliability and validity of the SDS was proven by Cleland et al., and the intraclass correlation coefficient (ICC) value was reported as 0.76.
Measured: From July 2023 to May 2024
Edema Assessment
The edema in the lower extremity was assessed by measuring the circumference with a tape measure. Each leg was recorded separately and the difference was calculated. A flexible, non-elastic, 7 mm wide standard tape measure with a sensitivity level of 0.1 cm was used in circumference measurements. The "0" (zero) end of the tape measure was wrapped around the area to be measured, with the other end in the left hand and the number on the "0" (zero) point noted. During the measurement, care was taken to ensure that the "0" (zero) point of the tape measure and the measurement number were side by side, not on top of each other, and the measurement was performed with the patient in the supine position in order to ensure standardization in each measurement. The circumference measurement values for each individual were converted to volumetric measurements by placing them in the Frustrum formula (truncated cone method).
Measured: From July 2023 to May 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start5 Jul 2023
- Primary completion10 May 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Çınar Özdemir, Izmir Democracy University
- Investigators
- Özlem Çinar Özdemir, Prof.Dr, Principal investigator, İzmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785805
- Sponsor's protocol ID
- IzmirDemocracy University
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831Ozdemir OC, Tonga E, Tekindal A, Bakar Y. Cross-cultural adaptation, reliability and validity of the Turkish version of the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20). Springerplus. 2016 Mar 31;5:381. doi: 10.1186/s40064-016-2039-2. eCollection 2016.
PubMed 27066388Kwon OY, Jung DY, Kim Y, Cho SH, Yi CH. Effects of ankle exercise combined with deep breathing on blood flow velocity in the femoral vein. Aust J Physiother. 2003;49(4):253-8. doi: 10.1016/s0004-9514(14)60141-0.
PubMed 14632624Osada T, Katsumura T, Hamaoka T, Murase N, Naka M, Shimomitsu T. Quantitative effects of respiration on venous return during single knee extension-flexion. Int J Sports Med. 2002 Apr;23(3):183-90. doi: 10.1055/s-2002-23177.
PubMed 11914981Tracz E, Zamojska E, Modrzejewski A, Zaborski D, Grzesiak W. Quality of life in patients with venous stasis ulcers and others with advanced venous insufficiency. Holist Nurs Pract. 2015 Mar-Apr;29(2):96-102. doi: 10.1097/HNP.0000000000000072.
PubMed 25658932
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Disease Severity, Pain, Lower Extremity Strength, Respiratory Functions, Aerobic Capacity and Quality of Life in Individuals With Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT06785805
- Acronym / sponsor ID
- IzmirDemocracy University
- Conditions
- Chronic Venous Insufficiency, CVI
- Keywords
- disease severity, chronic venous insufficiency, respiratory functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 21 Jan 2025 (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 study aims to retrospectively examine the dataset obtained from a previously conducted study titled 'Inspiratory muscle training in individuals with chronic venous insufficiency: randomized controlled trial'. The previously conducted study was a study investigating the effectiveness of the application, and the current study aims to clarify the gap in the literature with the relationship between the data obtained from the patients at the beginning of that study. This study will be conducted by re-examining the initial data of another study from which data was collected before and conducting new analyses.
H0: There is no relationship between disease severity, edema, pain, respiratory muscle strength, respiratory functions, aerobic capacity, lower extremity strength or quality of life in individuals with chronic venous insufficiency.
H1: There is a relationship between disease severity, edema, pain, respiratory muscle strength, respiratory functions, aerobic capacity, lower extremity strength or quality of life in individuals with chronic venous insufficiency.
Detailed description
Chronic Venous Insufficiency (CVI) is a term used to describe a disorder that affects the venous system of the lower extremities and results in venous hypertension. Venous pathology develops when venous pressure increases and the return of blood is impaired by various mechanisms. These pathologies are caused by valve insufficiency, venous obstruction or inadequate functioning of the muscle pump. The veins in the calf and the tissues surrounding them form the muscle pump. The muscle pump is responsible for venous blood circulation and is activated by ankle movements. In venous insufficiency, one-way valves and vein walls relax, resulting in muscle pump dysfunction. CVI can cause various pathologies and subjective symptoms such as leg pain and cramps, a feeling of heaviness, edema and skin changes. All these symptoms negatively affect the quality of life depending on the intensity of pain, severity of edema and the presence of inflammation. In CVI, the limitation of ankle movement is one of the factors that increase edema and venous severity. Fibrotic tissue formations in the lower extremity cause limitation in ankle movements. It should not be forgotten that functionality and quality of life are closely related phenomena, as the physical activity levels and functional capacity deterioration of people with chronic venous insufficiency increase, the quality of life decreases, which further worsens the prognosis of the disease. Complications of CVI impair the person's ability to participate in social or routine occupational activities, reduce working capacity, and ultimately increase the economic burden on the person and the family. Chronic venous diseases are a common condition that causes great socioeconomic effects due to their high prevalence. 32% of women and 40% of men have varicose veins. In addition, any type of venous disease affects 40-50% of men and 50-55% of women. CVI risk factors include heredity, pregnancy, aging, thrombosis, connective tissue laxity, inactivity, excessive weight, use of high-heeled shoes, standing for long periods, wearing tight clothes, being a woman, geographical effects and improper eating habits. Diagnosis of chronic venous disease is based on anamnesis, clinical symptoms and diagnostic tests. Today, duplex ultrasound is the gold standard for the diagnosis of CVI. The most widely used classification system for the classification of CVI is the CEAP classification system, which includes clinical, etiological, anatomical and pathophysiological effects and stages. In this classification, CEAP stands for; C: Clinical appearance, E: Etiological factors, A: Anatomical distribution, P: Pathophysiological condition. In general, C (clinical features)-classification is used in daily clinical practice. Insufficiency of the muscle pump includes not only calf muscle insufficiency but also respiratory muscle insufficiency. The diaphragm is a dome-shaped musculofibrous layer that separates the thorax and abdomen. The diaphragm, which acts as the main inspiratory muscle, creates a suction effect on the inferior vena cava during inspiration and expiration, allowing more blood flow from the lower extremities to the heart. Changes in pressure in the thoraco-abdominal region directly affect venous flow. Inspiration increases negative intrathoracic pressure, causing blood to be sucked into the thorax. Simultaneously, the diaphragm contracts and the abdominal veins are compressed. These changes in intrathoracic and intraabdominal pressures that occur with respiration help venous return by preventing retrograde flow in the veins. It has been shown that the respiratory cycle affects venous return in healthy individuals, and that the flow rate in the femoral vein increases with deep inspiration. However, no study has been found examining the relationship between disease severity, edema, pain, respiratory muscle strength, respiratory functions, aerobic capacity, lower extremity strength and quality of life in individuals with chronic venous insufficiency. For this reason, since the relationship between disease severity, disease symptoms, respiratory functions, aerobic capacity and quality of life in individuals with chronic venous insufficiency is unknown, this study aimed to clarify it.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with Chronic venous insufficiency | – | –Our prospective randomized controlled planned study named 'Inspiratory Muscle Training in Individuals with Chronic Venous Insufficiency: Randomized Controlled Study', which was approved by Izmir Democracy University Non-Interventional Clinical Research Ethics Committee on 21/06/2023 with the decision number 2023/08-02, was conducted. Although 38 individuals diagnosed with CVI were included in the study, the study was completed with 30 individuals diagnosed with CVI who could complete the 6-week follow-up. In the current study, which is a continuation of the previsious research; It is aimed to analyze the initial measurement results of 38 individuals diagnosed with CVI who were initially included in the study and to contribute these data to the literature with a retrospective cross-sectional study design. Our new hypothesis is based on the examination of the correlation between these initial outcome measurements obtained from our previous study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with chronic venous insufficiency volunteered to participate in the study
Key inclusion criteria (3 listed)
- Being diagnosed with chronic venous insufficiency
- Agreeing to participate in the study
- Being 18 years of age or older
Key exclusion criteria (6 listed)
- Presence of arterial diseases
- Presence of advanced cardiorespiratory diseases
- Presence of acute ulcers (< 3 months) and diabetic ulcers
- Being pregnant
- Presence of deep vein thrombosis
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
Disease severity
Time frame: From July 2023 to May 2024
The disease severity (CEAP scores) of the individuals referred to the study were determined by the cardiovascular surgeon.
7 secondary outcomes
Evaluation of Lower Extremity Strength
Time frame: From July 2023 to May 2024
Assessment of aerobic capacity
Time frame: From July 2023 to May 2024
Evaluation of respiratory functions
Time frame: From July 2023 to May 2024
Respiratory muscle strength assessment
Time frame: From July 2023 to May 2024
Quality of life assessment
Time frame: From July 2023 to May 2024
Pain Assessment
Time frame: From July 2023 to May 2024
Edema Assessment
Time frame: From July 2023 to May 2024
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 21 Jan 2025.
- Background: PubMed 12186831American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
- Background: PubMed 27066388Ozdemir OC, Tonga E, Tekindal A, Bakar Y. Cross-cultural adaptation, reliability and validity of the Turkish version of the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20). Springerplus. 2016 Mar 31;5:381. doi: 10.1186/s40064-016-2039-2. eCollection 2016.
- Background: PubMed 14632624Kwon OY, Jung DY, Kim Y, Cho SH, Yi CH. Effects of ankle exercise combined with deep breathing on blood flow velocity in the femoral vein. Aust J Physiother. 2003;49(4):253-8. doi: 10.1016/s0004-9514(14)60141-0.
- Background: PubMed 11914981Osada T, Katsumura T, Hamaoka T, Murase N, Naka M, Shimomitsu T. Quantitative effects of respiration on venous return during single knee extension-flexion. Int J Sports Med. 2002 Apr;23(3):183-90. doi: 10.1055/s-2002-23177.
- Background: PubMed 25658932Tracz E, Zamojska E, Modrzejewski A, Zaborski D, Grzesiak W. Quality of life in patients with venous stasis ulcers and others with advanced venous insufficiency. Holist Nurs Pract. 2015 Mar-Apr;29(2):96-102. doi: 10.1097/HNP.0000000000000072.
- 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.
Özlem Çinar Özdemir, Prof.Dr principal investigator
İzmir Democracy University
1 site 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 Insufficiency, CVI, run by Izmir Democracy 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 3 inclusion and 6 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 21 Jan 2025. 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?
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?
Disease severity (time frame: From July 2023 to May 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06785805, which also lists 5 linked publications.
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 21 Jan 2025.