Pathology, Venous Disease, and Clinical Correlations
- Conditions
- PathologyVaricose VeinsSymptoms and Signs
- Interventions
- Procedure: Stab Avulsion of varicose veinsDiagnostic Test: Histopathologic evaluation of varicose veins
- Registration Number
- NCT04436549
- Lead Sponsor
- University of Catanzaro
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Patients with varicose veins scheduled for surgery
- Peripheral artery disease
- Malignancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with varicose veins Stab Avulsion of varicose veins Patients with varicose veins and eligible to receive open surgery (stab avulsion of varicose veins) as routinely care. Patients with varicose veins Histopathologic evaluation of varicose veins Patients with varicose veins and eligible to receive open surgery (stab avulsion of varicose veins) as routinely care.
- Primary Outcome Measures
Name Time Method Expression of Fibronectin at 10 month 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.
Expression of Matrix Metalloproteinase-9 (MMP-9) at 10 month 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).
Expression of Vascular Endothelial Growth Factor (VEGF) at 10 month 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).
Expression of Protein Gene Product 9.5 (PGP 9.5) at 10 month 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
- Secondary Outcome Measures
Name Time Method Correlation of the biomarkers expression with signs and symptoms At 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.
Trial Locations
- Locations (2)
CIFL- Interuniversity Center of Phlebolymphology
🇮🇹Catanzaro, Italy
University Magna Graecia of Catanzaro
🇮🇹Catanzaro, Italy