Varicose Veins Clinical Trial
Official title:
The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy
NCT number | NCT05058989 |
Other study ID # | 20HH5790 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | December 1, 2022 |
Verified date | October 2023 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Varicose veins (VV) are the early sign of Chronic venous insufficiency (CVI) which are characterised by abnormal tortuosity and dilatation of superficial veins of lower limb extremities. Factors for the development of VV exist in literature. However, the exact mechanism remains unclear. The prevalence of VV are greater in women compared to men and also higher in pregnant women compared to non-pregnant women which make pregnant women at higher risk of developing VV. Furthermore, complications of VV have negative impacts on patients' quality of life and health care budget. Therefore, better understanding of the cause of VV can contribute in better quality of life to the patient and provide valuable insights to help in reducing health care cost. The present study will investigate the contribution of both mechanical and chemical factors in pregnant women by taking blood samples for genomic testing, using Duplex ultrasound, vector flow imaging, limb volume assessment using Truncated cone tool, assessment of iliac vein compression using Photoplethysmography (PPG) technique, hormonal blood test and assessing patient's quality of life using Aberdeen Varicose Veins Questionnaire (AVVQ).
Status | Completed |
Enrollment | 70 |
Est. completion date | December 1, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 47 Years |
Eligibility | Inclusion Criteria: - Patients who are willing to be followed up for 1 year and agreeing to give the informed consent will be included in the inclusion criteria. Exclusion Criteria: - Any incomplete cases such as intrauterine death. - Participants who fail to attend the scans after their first visit will be excluded. - Patients with congenital vascular abnormalities/syndromes such as Klippel Klippel-Trenaunay syndrome. - Patients who are unable to provide consent. - Anyone who are 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. - Patients with signs of acute deep vein thrombosis. - Patient suffered from severe injury of their great-saphenous vein |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College London | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
Evans CJ, Fowkes FG, Hajivassiliou CA, Harper DR, Ruckley CV. Epidemiology of varicose veins. A review. Int Angiol. 1994 Sep;13(3):263-70. — View Citation
Fukaya E, Flores AM, Lindholm D, Gustafsson S, Zanetti D, Ingelsson E, Leeper NJ. Clinical and Genetic Determinants of Varicose Veins. Circulation. 2018 Dec 18;138(25):2869-2880. doi: 10.1161/CIRCULATIONAHA.118.035584. — View Citation
Ismail L, Normahani P, Standfield NJ, Jaffer U. A systematic review and meta-analysis of the risk for development of varicose veins in women with a history of pregnancy. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):518-524.e1. doi: 10.1016/j.jvsv.2016.06.003. Epub 2016 Aug 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The patency of the vein, the blood flow direction (antegrade/retrograde) and the peak reflux velocity are evaluated by Duplex ultrasound parameters. | Blood vein has to be patent to exclude blood clots, blood flow direction has to be antegrade to exclude backward flow (reflux) and peak reflux velocity has to be less than 0.5 seconds to be considered normal. | 1 year, in each follow up (first, second, third trimester and three months after giving birth) | |
Secondary | The patency of the vein, the blood flow direction (antegrade/retrograde) and the peak reflux velocity are evaluated by Vector flow imaging. | Blood vein has to be patent to exclude blood clots, blood flow direction has to be antegrade to exclude backward flow (reflux) and peak reflux velocity has to be less than 0.5 seconds to be considered normal. | 1 year, in each follow up (first, second, third trimester and three months after giving birth) | |
Secondary | Measuring the lower limb volume by Truncated cone tool. | Measuring legs circumferences at two points C1 and C2 and the height between them (H) and then applying an equation. | 1 year, in each follow up (first, second, third trimester and three months after giving birth) | |
Secondary | Measuring the iliac vein compression using the PPG technique. | This technique measures the severity of venous reflux by measuring Venous refiling time (VRT) , (Abnormal less than 20 sec). | 1 year, in each follow up (first, second, third trimester and three months after giving birth) | |
Secondary | Genomic blood test | Using a blood sample to assess the patient DNA (to analyze genes that associate with the development of varicose veins ) and correlating these findings with the UK biobank study. | Through study completion, an average of 1 year. | |
Secondary | Hormonal blood test | Using a blood sample to assess two hormones (Estriol (E3) and progesterone serum levels. | 1 year, in each follow up (first, second, third trimester and three months after giving birth) | |
Secondary | The impact of varicose veins on the patient quality of life | Patient's quality of life will be measured using Aberdeen varicose vein questionaire (AVVQ). | 1 year, in each follow up (first, second, third trimester and three months after giving birth) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02441881 -
Trial of Radiofrequency Thermo-ablation Treatments of Great Saphenous Varicose Veins (3-RF Study)
|
N/A | |
Completed |
NCT03283800 -
Copper Impact on Venous Insufficiency and Lipodermatosclerosis
|
N/A | |
Recruiting |
NCT02676908 -
Optimum Duration of Compression Stockings After Endovenous Varicose Vein Surgery
|
N/A | |
Withdrawn |
NCT01203397 -
Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate In The Superficial Varicose Veins Treatment
|
Phase 3 | |
Withdrawn |
NCT01426035 -
Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins Treatment
|
Phase 3 | |
Recruiting |
NCT02054325 -
Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins
|
Phase 4 | |
Withdrawn |
NCT03601572 -
Hypnoanalgesia in Surgical and Endovenous Treatment of Varicosis
|
||
Completed |
NCT04933591 -
Impact of Treatment With VENARUS® on the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood
|
N/A | |
Active, not recruiting |
NCT02397226 -
Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery
|
N/A | |
Withdrawn |
NCT02936271 -
Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting
|
N/A | |
Terminated |
NCT02557542 -
Pilot RCT Evaluating a One Stop Vein Clinic
|
N/A | |
Completed |
NCT00758420 -
Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT00841178 -
Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT
|
N/A | |
Not yet recruiting |
NCT05508581 -
Microwaves Ablation of Varicose Veins
|
N/A | |
Completed |
NCT05247333 -
Implementation of a Minor Ailment Service in Community Pharmacy Practice
|
N/A | |
Active, not recruiting |
NCT04339075 -
Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
|
||
Completed |
NCT03392753 -
Mechanochemical Ablation Compared to Cyanoacrylate Adhesive
|
N/A | |
Recruiting |
NCT04146168 -
Lake Washington Vascular VenaSealâ„¢ Post-Market Evaluation
|
||
Recruiting |
NCT02304146 -
Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study
|
N/A | |
Completed |
NCT01200199 -
Validity of Electronic Diary for Monitoring Varicose Veins Symptoms
|