- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04794712
Evaluation of Pain Associated With Chronic Venous Insufficiency
The Evaluation of Pain Severity in the Lower Limb Caused by Chronic Venous Insufficiency
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Dr Mohammed Aslam, PhD
- Phone Number: +44 20 3313 1541
- Email: m.aslam@imperial.ac.uk
Study Contact Backup
- Name: Bedor K Alsoliman, MSc
- Phone Number: + 44 7380900066
- Email: b.alsoliman18@imperial.ac.uk
Study Locations
-
-
England
-
London, England, United Kingdom, W12 0HS
- Imperial College London
-
Contact:
- Bedor K Alsoliman, MSc
- Phone Number: + 44 7380900066
- Email: b.alsoliman18@imperial.ac.uk
-
Contact:
- Dr Mohammed Aslam, PhD
- Phone Number: +44 2083831541
- Email: m.aslam@imperial.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥ 18 years ago
- Patient with Chronic venous Insufficiency
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study group A
Participants group: Group A : 20 participants with chronic venous insufficiency
|
Venous reflux tools Pain assessment tools
Other Names:
|
Study group B
Participants group: Group B : 20 participants with chronic venous insufficiency
|
Venous reflux tools Pain assessment tools
Other Names:
|
Study Group C
Participants group: Control Group C : 40 participants with chronic venous insufficiency SUBGROUP 1: WITHOUT EXERCISE 20 PARTICIPANTS
SUBGROUP 2: 3 MONTHS EXERCISE 20 PARTICIPANTS
|
Venous reflux tools Pain assessment tools
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vein competency according to ultrasound and PPG parameters
Time Frame: baseline
|
Detect presence of the reflux or not
|
baseline
|
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) .
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual analogue scale (VAS)
Time Frame: baseline
|
measure the intensity of chronic pain
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dr Mohammed Aslam, PhD, Academic Supervisor
Publications and helpful links
General Publications
- 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.
- 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.
- DANZIGER, N. 2008. Hypothesis on the origin of pain. Phlebolymphology, 15, 107-114.
- GUJJA, K., SANINA, C. & WILEY, J. M. 2017. Chronic venous insufficiency. Interventional Cardiology: Principles and Practice, 759-767.
- Reinhardt 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21HH6669
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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