NCT04436549|UnknownDMC
Pathology, Venous Disease, and Clinical Correlations
PAVEDI
Clinical and Pathological Correlations in Chronic Venous Disease
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PAVEDI
Clinical and Pathological Correlations in Chronic Venous Disease
Sponsor study identifier
observational
100
1 country
2
Study Start
December 1, 2019
Actual (reported)Primary Completion
September 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Chronic Venous Disease (CVD) has a high prevalence in the general population of the western world. Varicose veins are the main signs of this disease that are characterized by important pathological vessel wall changes. There are also several symptoms that affect the quality of life of affected patients. The aim of this study is to correlate the main histopathological abnormalities with the type and the intensity of the symptoms.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2019
Actual (reported)June 15, 2020
Actual (reported)June 18, 2020
Actual (reported)September 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Expression of Matrix Metalloproteinase-9 (MMP-9)
EnVision staining system (Dako EnVision™) will be used. A synthetic peptide from the middle region of human MMP9 will be used with dilutions 1:50 with Ethylenediaminetetraacetic acid (EDTA).
at 10 month
Expression of Vascular Endothelial Growth Factor (VEGF)
EnVision staining system (Dako EnVision™) will be used. Monoclonal mouse Anti-Human vascular endothelial growth factor, code No. M7273 will be used with dilution 1:50 with Ethylenediaminetetraacetic acid (EDTA).
at 10 month
Expression of Fibronectin
EnVision staining system (Dako EnVision™) will be used. A synthetic peptide made toward the C-terminal region of the human Fibronectin protein (within residues 2250-2300) will be used with dilution 1:400 citrate buffer.
at 10 month
Expression of Protein Gene Product 9.5 (PGP 9.5)
Correlation of the biomarkers expression with signs and symptoms
At 11 month.
Patients with varicose veins and eligible to receive open surgery (stab avulsion of varicose veins) as routinely care.
Stab avulsion is a technique to remove varicose veins. In this procedure, several tiny cuts (incisions) are made in the skin through which the varicosed vein is removed. Removed varicose veins will be collected and analyzed.
Patients with varicose veins that are scheduled to undergo surgery for varicose veins removal.
CIFL- Interuniversity Center of Phlebolymphology
Catanzaro, 88100, Italy
University Magna Graecia of Catanzaro
Catanzaro, 88100, Italy
Birdina J, Pilmane M, Ligers A. The Morphofunctional Changes in the Wall of Varicose Veins. Ann Vasc Surg. 2017 Jul;42:274-284. doi: 10.1016/j.avsg.2016.10.064. Epub 2017 Mar 11.
Kucukguven A, Khalil RA. Matrix metalloproteinases as potential targets in the venous dilation associated with varicose veins. Curr Drug Targets. 2013 Mar;14(3):287-324.
Kolano P, Bednarski IA, Lesiak A, Skibinska M, Stasikowska-Kanicka O, Danilewicz M, Narbutt J. Overexpression of cathepsin K and vascular endothelial growth factor in chronic venous ulcerations. Postepy Dermatol Alergol. 2020 Apr;37(2):234-239. doi: 10.5114/ada.2020.94840. Epub 2020 May 6.
Raffaele Serra, M.D., Ph.D.
University Magna Graecia of Catanzaro
First Submitted
June 15, 2020
First Posted
June 18, 2020
Study Start
December 1, 2019
Actual (reported)Primary Completion
September 1, 2020
Estimated (date passed)Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?
EnVision staining system (Dako EnVision™) will be used. Purified PGP 9.5 isolated from bovine brain will be used with dilution 1:200 citrate buffer
at 10 month
Sample obtained from varicose veins of lower limbs of patients will be collected and immediately fixed in formalin. The tissue fragments will be taken from varicose veins. Subsequently the tissue will be embedded in paraffin and 3-to-4 mm thick sections will be prepared by a microtome. The tissue sections will be processed for histological and immunohistochemical studies of VEGF, MM9, PGP 9.5 AND FRIBRONECTIN. For antibodies the EnVision staining system (Dako EnVision™) will be used. For the analysis of the positive structures detected by immunohistochemistry, a semiquantitative evaluation method will be used.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 18, 2020
Record last verified: 2020-06
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