Pathology, Venous Disease, and Clinical Correlations

NCT04436549 | Unknown DMC

• 1 other identifier: ER.ALL.2018.11
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Varicose Veins; Pathology; Symptoms and Signs

Keywords

pathology; varicose veins; chronic venous disease; symptoms

Outcome Measures

Primary Outcomes (4)

• 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)

  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

Secondary Outcomes (1)

• Correlation of the biomarkers expression with signs and symptoms

  At 11 month.

Study Arms (1)

Patients with varicose veins

Patients with varicose veins and eligible to receive open surgery (stab avulsion of varicose veins) as routinely care.

Procedure: Stab Avulsion of varicose veins; Diagnostic Test: Histopathologic evaluation of varicose veins

Interventions

Stab Avulsion of varicose veins PROCEDURE

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.

Also known as: Phlebectomy

Patients with varicose veins

Histopathologic evaluation of varicose veins DIAGNOSTIC_TEST

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.

Patients with varicose veins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with varicose veins that are scheduled to undergo surgery for varicose veins removal.

You may qualify if:

• Patients with varicose veins scheduled for surgery

You may not qualify if:

• Peripheral artery disease
• Malignancy

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (2)

CIFL- Interuniversity Center of Phlebolymphology

Catanzaro, 88100, Italy

RECRUITING

University Magna Graecia of Catanzaro

Catanzaro, 88100, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 28300675 BACKGROUND

• 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.

  PMID: 23316963 BACKGROUND

• 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.

  PMID: 32489360 BACKGROUND

MeSH Terms

Conditions

Varicose Veins; Signs and Symptoms

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms

Study Officials

• Raffaele Serra, M.D., Ph.D.

  University Magna Graecia of Catanzaro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele Serra, M.D., Ph.D.

CONTACT

+3909613647380; rserra@unicz.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Vascular Surgery

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 18, 2020
• Study Start: December 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)