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Pathology, Venous Disease, and Clinical Correlations

Clinical and Pathological Correlations in Chronic Venous Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04436549
Acronym
PAVEDI
Enrollment
100
Registered
2020-06-18
Start date
2019-12-01
Completion date
2020-10-01
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pathology, Symptoms and Signs, Varicose Veins

Keywords

pathology, varicose veins, chronic venous disease, symptoms

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.

Detailed description

Chronic Venous Disease (CVD) of the lower limbs is a widespread chronic condition of the western world. There are several signs and symptoms that affect quality of life of patients with CVD. One of the main signs of this disease are varicose veins that are enlarged, swollen, and twisting superficial veins. Vessel wall of varicose veins shows a significant histopathological phenotype, characterized by a distortion of structural architecture: endothelial damage, disorganization of muscle bundles and alteration of the composition of the extracellular matrix (ECM). Symptoms may be different, according to disease state, progression and local inflammatory processes. To date, there is no study that correlate the type and the intensity of symptoms with histopathological phenotype. Aim of this study is to correlate histopathological phenotype with clinical manifestations. A cohort of patients with varicose veins scheduled for open surgical treatment that will undergo to stab avulsion of varicose veins will be recruited. Subsequently, venous tissue from stab avulsion will collected in order to evaluate the following biomarkers: VEGF (Vascular -Endothelial Growth Factor), PGP 9.5 (Protein Gene Product 9.5), Fibronectin and Matrix Metalloproteinase- 9 (MMP-9). VEGF has a key role as a regulator of angiogenesis; its expression is highly regulated by hypoxia, in this case induced by venous hypertension. In addition to being a marker of neoangiogenesis, it increases vascular permeability in inflammatory disorders. PGP 9.5 is a marker of the innervation of the vessel wall that plays an important role in the regulation of venous tone. Fibronectin and MMP-9 are direct markers of ECM remodeling and impairment and they have also a role in chronic inflammation.

Interventions

PROCEDUREStab Avulsion of varicose veins

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.

DIAGNOSTIC_TESTHistopathologic evaluation of varicose veins

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.

Sponsors

University of Catanzaro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with varicose veins scheduled for surgery

Exclusion criteria

* Peripheral artery disease * Malignancy

Design outcomes

Primary

MeasureTime frameDescription
Expression of Matrix Metalloproteinase-9 (MMP-9)at 10 monthEnVision 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).
Expression of Vascular Endothelial Growth Factor (VEGF)at 10 monthEnVision 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).
Expression of Fibronectinat 10 monthEnVision 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.
Expression of Protein Gene Product 9.5 (PGP 9.5)at 10 monthEnVision staining system (Dako EnVision™) will be used. Purified PGP 9.5 isolated from bovine brain will be used with dilution 1:200 citrate buffer

Secondary

MeasureTime frameDescription
Correlation of the biomarkers expression with signs and symptomsAt 11 month.The expression of the biomarkers that will be studied on venous tissue samples will be correlated with the type of signs and symptoms complained by the patients.

Countries

Italy

Contacts

Primary ContactRaffaele Serra, M.D., Ph.D.
rserra@unicz.it+3909613647380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026