- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04436549
Pathology, Venous Disease, and Clinical Correlations (PAVEDI)
Clinical and Pathological Correlations in Chronic Venous Disease
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Catanzaro, Italie, 88100
- Recrutement
- CIFL- Interuniversity Center of Phlebolymphology
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Catanzaro, Italie, 88100
- Recrutement
- University Magna Graecia of Catanzaro
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients with varicose veins scheduled for surgery
Exclusion Criteria:
- Peripheral artery disease
- Malignancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Transversale
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Patients with varicose veins
Patients with varicose veins and eligible to receive open surgery (stab avulsion of varicose veins) as routinely care.
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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.
Autres noms:
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Expression of Matrix Metalloproteinase-9 (MMP-9)
Délai: at 10 month
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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).
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at 10 month
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Expression of Vascular Endothelial Growth Factor (VEGF)
Délai: at 10 month
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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).
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at 10 month
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Expression of Fibronectin
Délai: at 10 month
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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.
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at 10 month
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Expression of Protein Gene Product 9.5 (PGP 9.5)
Délai: at 10 month
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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
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at 10 month
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Correlation of the biomarkers expression with signs and symptoms
Délai: At 11 month.
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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.
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At 11 month.
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ER.ALL.2018.11
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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