Chronic Venous InsufficiencyNCT04794712
Evaluation of Pain Associated With Chronic Venous Insufficiency
An observational study of Chronic Venous Insufficiency and Varicose Veins of Lower Limb, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Chronic venous insufficiency occurs when your leg veins don't allow blood to flow back up to your heart. Normally, the valves in your veins make sure that blood flows toward your heart. But when these valves don't work well, blood can also flow backwards. This can cause blood to collect (pool) in the legs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency, Varicose Veins of Lower Limb
- What is being tested?
- Venous reflux tools (Ultrasound and Photo plethysmography (PPG))
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2021to 14 May 2022
- How long will I take part?
- 3 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have chronic venous insufficiency (Varicose veins)
Who may be able to join
- ≥ 18 years ago
- Patient with Chronic venous Insufficiency
Who cannot join
- Pregnant patients
- Cancer
- Patients who unable to exercise
- Exclude anyone who is taking part in any other research
- Potential participants who might not adequately understand verbal explanations or written information given in English, or who have special communication needs will not be included.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London
London, England, W12 0HS
Dr Mohammed Aslam, PhD, +44 2083831541, m.aslam@imperial.ac.uk
Bedor K Alsoliman, MSc, + 44 7380900066, b.alsoliman18@imperial.ac.uk
About this study
Official title: The Evaluation of Pain Severity in the Lower Limb Caused by Chronic Venous Insufficiency
Chronic venous insufficiency occurs when your leg veins don't allow blood to flow back up to your heart. Normally, the valves in your veins make sure that blood flows toward your heart. But when these valves don't work well, blood can also flow backwards. This can cause blood to collect (pool) in the legs. Chronic venous disease is a highly prevalent condition in the general population, and it has a significant impact on quality of life. While it is usually manifested by obvious signs, such as varicose veins and venous ulcers, other symptoms of the disease are less specific. Among the other symptoms, which include heaviness, swelling, muscle cramps and restless legs, pain is the symptom that most frequently compels CVeD patients to seek medical aid. However, there is a substantial discrepancy between pain severity and clinically detectable signs of CVeD, questioned by several opposing studies. Further evaluation is needed to clarify this subject, and to analyse whether pain development predicts objective tool to evaluate pain by dosflexin exercise pre surgery and post and measure the severity of pain by heat stimulation . General management of CVeD starts with advising lifestyle . pain in chronic venous insufficiency it will measure before and after treatment by using contact heat evoked potential (CHEPS) and visual dialog scale ( VAS ) to estimate the pain intensity the severity of the pain before the patient do exercise before three moths of leaser endovenous ablation procedure . 2-photo-plethysomography Non invasive technique , pp sensor emit infrared light detects changes in reflection from epiderma layer . Vessels full of blood reflect 10 times less than without blood . On dorsiflexion - pressure drops, increasing reflection in the measuring window Venous assessment the venous refill time, is shorter and typically less than 20 s
Read the detailed description
The study will have no interventional procedures. Participants who will be attending for routine Ultrasound scan for assessment of venous insufficiency , assessment evaluation of pain and participants meets our study's inclusion criteria will be provided with full research information, if they decide to participate. Once the routine assessment is done. Ultrasound will be performed to obtain the following parameters:
the RT (second), the PRV (cm/s) and the flow at peak reflux(mL/s) . photo plethysmography (PPG) can be used to measure the severity of the venous reflux disease time (RT).
Therefore, if advanced ultrasound applications can promise a precise, cost-effective, convenient, and repeatable results for the follow-up of CVI , it would be of an extreme benefit to use ultrasound scan diagnoses anatomy of lower limb for Chronic venous insufficiency patients rather than PPG . photoplethysmography : the non-invasive technique of assessing pressure without a needle .
assessment evaluation of pain CHEPS (contact heat evoked potentials ): a beneficial objective tool to measure small nerve fibre function CHEPS provides a clinically practical, non-invasive and objective measure, .Therefore heat pulses could be annoying for the patient .and it is cost effectetive machine and require a special training .
VAS visual analogue scale :
Subjective tool to measure the intensity of chronic and acute pain.some of this tool issue is a sensitive tool to use by patients and there is some changes in pain intensities because it is little variable
- Being tested
- Venous reflux tools (Ultrasound and Photo plethysmography (PPG))
- Keywords
- photo plethysmography (PPG), contact heat evoked potentials (CHEPS), Varicose Veins, Chronic Venous Insufficiency, Ultrasound, leg pain
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous reflux tools (Ultrasound and Photo plethysmography (PPG))Device
Also called Pain assessment tools (contact heat evoked potential (CHEPS))
Venous reflux tools Pain assessment tools
| Study group | Role | What they receive |
|---|---|---|
| Study group A | Participants group: Group A : 20 participants with chronic venous insufficiency
* 3 months exercise pre surgery
* Pre-surgery evaluation
* Venous reflux assessment by ultrasound and PPG
* Pain assessment by CHEPS,VAS QS MCGILL
* 3 months exercise post surgery
* Post surgery evaluation by US, PPG, CHEPS and VAS QS MCGILL. Receives: Device: Venous reflux tools (Ultrasound and Photo plethysmography (PPG)) | |
| Study group B | Participants group: Group B : 20 participants with chronic venous insufficiency
* Pre-surgery evaluation
* Venous reflux assessment by ultrasound and PPG
* Pain assessment by CHEPS,VAS QS MCGILL
* Post surgery evaluation by US, PPG, CHEPS and VAS QS MCGILL. Receives: Device: Venous reflux tools (Ultrasound and Photo plethysmography (PPG)) | |
| Study Group C | Participants group: Control Group C : 40 participants with chronic venous insufficiency SUBGROUP 1: WITHOUT EXERCISE 20 PARTICIPANTS
* VENOUS ASSESSMENT TOOLS( U/S, PPG )
* PAIN ASSESSMENT TOOLS (CHEPS VAS, MCGILL)
SUBGROUP 2: 3 MONTHS EXERCISE 20 PARTICIPANTS
* VENOUS ASSESSMENT TOOLS ( U/S, PPG )
* PAIN ASSESSMENT TOOLS (CHEPS VAS, MCGILL) Receives: Device: Venous reflux tools (Ultrasound and Photo plethysmography (PPG)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vein competency according to ultrasound and PPG parameters
Detect presence of the reflux or not
Measured: baseline
Pain sensation according to CHEPS parameters
Experience pain to heat stimulus , and the response increases with temperature into the painful range(40 to 46 degree) .
Measured: baseline
Secondary outcomes (1)
visual analogue scale (VAS)
measure the intensity of chronic pain
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start15 May 2021 (estimated)
- Primary completion14 May 2022 (estimated)
- Study completion14 May 2022 (estimated)
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 InsufficiencyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Mohammed Aslam, PhD, Study director, Academic Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794712
- Sponsor's protocol ID
- 21HH6669
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ALGUIRE, P. C. & MATHES, B. M. 2017. Diagnostic evaluation of lower extremity chronic ve-nous insufficiency. UpToDate. Retrieved from http://www.uptodate. com/contents/diagnostic-evaluation-of-chronic-venous-insufficiency.
Andreozzi GM, Cordova RM, Scomparin A, Martini R, D'Eri A, Andreozzi F; Quality of Life Working Group on Vascular Medicine of SIAPAV. Quality of life in chronic venous insufficiency. An Italian pilot study of the Triveneto Region. Int Angiol. 2005 Sep;24(3):272-7.
PubMed 16158038DANZIGER, N. 2008. Hypothesis on the origin of pain. Phlebolymphology, 15, 107-114.
Gujja K, Wiley J, Krishnan P. Chronic Venous Insufficiency. Interv Cardiol Clin. 2014 Oct;3(4):593-605. doi: 10.1016/j.iccl.2014.07.001. Epub 2014 Oct 2.
PubMed 28582082Reinhardt F, Wetzel T, Vetten S, Radespiel-Troger M, Hilz MJ, Heuss D, Neundorfer B. Peripheral neuropathy in chronic venous insufficiency. Muscle Nerve. 2000 Jun;23(6):883-7. doi: 10.1002/(sici)1097-4598(200006)23:63.0.co;2-t.
PubMed 10842263
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Pain Severity in the Lower Limb Caused by Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT04794712
- Acronym / sponsor ID
- 21HH6669
- Keywords
- photo plethysmography (PPG), contact heat evoked potentials (CHEPS), Varicose Veins, Chronic Venous Insufficiency, Ultrasound, leg pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 15 May 2021 (estimated)
- Primary completion
- 14 May 2022 (estimated)
- Study completion
- 14 May 2022 (estimated)
- First posted
- 12 Mar 2021 (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.
Chronic venous insufficiency occurs when your leg veins don't allow blood to flow back up to your heart. Normally, the valves in your veins make sure that blood flows toward your heart. But when these valves don't work well, blood can also flow backwards. This can cause blood to collect (pool) in the legs. Chronic venous disease is a highly prevalent condition in the general population, and it has a significant impact on quality of life. While it is usually manifested by obvious signs, such as varicose veins and venous ulcers, other symptoms of the disease are less specific. Among the other symptoms, which include heaviness, swelling, muscle cramps and restless legs, pain is the symptom that most frequently compels CVeD patients to seek medical aid. However, there is a substantial discrepancy between pain severity and clinically detectable signs of CVeD, questioned by several opposing studies. Further evaluation is needed to clarify this subject, and to analyse whether pain development predicts objective tool to evaluate pain by dosflexin exercise pre surgery and post and measure the severity of pain by heat stimulation . General management of CVeD starts with advising lifestyle . pain in chronic venous insufficiency it will measure before and after treatment by using contact heat evoked potential (CHEPS) and visual dialog scale ( VAS ) to estimate the pain intensity the severity of the pain before the patient do exercise before three moths of leaser endovenous ablation procedure . 2-photo-plethysomography Non invasive technique , pp sensor emit infrared light detects changes in reflection from epiderma layer . Vessels full of blood reflect 10 times less than without blood . On dorsiflexion - pressure drops, increasing reflection in the measuring window Venous assessment the venous refill time, is shorter and typically less than 20 s
Detailed description
The study will have no interventional procedures. Participants who will be attending for routine Ultrasound scan for assessment of venous insufficiency , assessment evaluation of pain and participants meets our study's inclusion criteria will be provided with full research information, if they decide to participate. Once the routine assessment is done. Ultrasound will be performed to obtain the following parameters:
the RT (second), the PRV (cm/s) and the flow at peak reflux(mL/s) . photo plethysmography (PPG) can be used to measure the severity of the venous reflux disease time (RT).
Therefore, if advanced ultrasound applications can promise a precise, cost-effective, convenient, and repeatable results for the follow-up of CVI , it would be of an extreme benefit to use ultrasound scan diagnoses anatomy of lower limb for Chronic venous insufficiency patients rather than PPG . photoplethysmography : the non-invasive technique of assessing pressure without a needle .
assessment evaluation of pain CHEPS (contact heat evoked potentials ): a beneficial objective tool to measure small nerve fibre function CHEPS provides a clinically practical, non-invasive and objective measure, .Therefore heat pulses could be annoying for the patient .and it is cost effectetive machine and require a special training .
VAS visual analogue scale :
Subjective tool to measure the intensity of chronic and acute pain.some of this tool issue is a sensitive tool to use by patients and there is some changes in pain intensities because it is little variable
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group A | – | Device: Venous reflux tools (Ultrasound and Photo plethysmography (PPG))Participants group: Group A : 20 participants with chronic venous insufficiency * 3 months exercise pre surgery * Pre-surgery evaluation * Venous reflux assessment by ultrasound and PPG * Pain assessment by CHEPS,VAS QS MCGILL * 3 months exercise post surgery * Post surgery evaluation by US, PPG, CHEPS and VAS QS MCGILL. |
| Study group B | – | Device: Venous reflux tools (Ultrasound and Photo plethysmography (PPG))Participants group: Group B : 20 participants with chronic venous insufficiency * Pre-surgery evaluation * Venous reflux assessment by ultrasound and PPG * Pain assessment by CHEPS,VAS QS MCGILL * Post surgery evaluation by US, PPG, CHEPS and VAS QS MCGILL. |
| Study Group C | – | Device: Venous reflux tools (Ultrasound and Photo plethysmography (PPG))Participants group: Control Group C : 40 participants with chronic venous insufficiency SUBGROUP 1: WITHOUT EXERCISE 20 PARTICIPANTS * VENOUS ASSESSMENT TOOLS( U/S, PPG ) * PAIN ASSESSMENT TOOLS (CHEPS VAS, MCGILL) SUBGROUP 2: 3 MONTHS EXERCISE 20 PARTICIPANTS * VENOUS ASSESSMENT TOOLS ( U/S, PPG ) * PAIN ASSESSMENT TOOLS (CHEPS VAS, MCGILL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have chronic venous insufficiency (Varicose veins)
Key inclusion criteria (2 listed)
- ≥ 18 years ago
- Patient with Chronic venous Insufficiency
Key exclusion criteria (5 listed)
- Pregnant patients
- Cancer
- Patients who unable to exercise
- Exclude anyone who is taking part in any other research
- Potential participants who might not adequately understand verbal explanations or written information given in English, or who have special communication needs will not be included.
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 |
|---|---|---|
| Venous reflux tools (Ultrasound and Photo plethysmography (PPG))Also: Pain assessment tools (contact heat evoked potential (CHEPS))Venous reflux tools Pain assessment tools | Device | Study Group C, Study group A, Study group B |
Primary outcome
Vein competency according to ultrasound and PPG parameters
Time frame: baseline
Detect presence of the reflux or not
Pain sensation according to CHEPS parameters
Time frame: baseline
Experience pain to heat stimulus , and the response increases with temperature into the painful range(40 to 46 degree) .
1 secondary outcome
visual analogue scale (VAS)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- BackgroundALGUIRE, P. C. & MATHES, B. M. 2017. Diagnostic evaluation of lower extremity chronic ve-nous insufficiency. UpToDate. Retrieved from http://www.uptodate. com/contents/diagnostic-evaluation-of-chronic-venous-insufficiency.
- Background: PubMed 16158038Andreozzi GM, Cordova RM, Scomparin A, Martini R, D'Eri A, Andreozzi F; Quality of Life Working Group on Vascular Medicine of SIAPAV. Quality of life in chronic venous insufficiency. An Italian pilot study of the Triveneto Region. Int Angiol. 2005 Sep;24(3):272-7.
- BackgroundDANZIGER, N. 2008. Hypothesis on the origin of pain. Phlebolymphology, 15, 107-114.
- Background: PubMed 28582082Gujja K, Wiley J, Krishnan P. Chronic Venous Insufficiency. Interv Cardiol Clin. 2014 Oct;3(4):593-605. doi: 10.1016/j.iccl.2014.07.001. Epub 2014 Oct 2.
- Background: PubMed 10842263Reinhardt F, Wetzel T, Vetten S, Radespiel-Troger M, Hilz MJ, Heuss D, Neundorfer B. Peripheral neuropathy in chronic venous insufficiency. Muscle Nerve. 2000 Jun;23(6):883-7. doi: 10.1002/(sici)1097-4598(200006)23:63.0.co;2-t.
- 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.
Dr Mohammed Aslam, PhD study director
Academic Supervisor
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 and Varicose Veins of Lower Limb, run by Imperial College London at 1 site in United Kingdom.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Mar 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Mohammed Aslam, PhD (+44 20 3313 1541, m.aslam@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vein competency according to ultrasound and PPG parameters (time frame: baseline). 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?
On the ClinicalTrials.gov record for NCT04794712, 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 12 Mar 2021.