Gene Expression in Chronic Venous Leg Ulcers

NCT05134597 | Unknown DMC

• 1 other identifier: E.R.ALL.2018.42
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Venous Disease (CVD) is a widespread clinical condition widely spread in the western countries that may negatively impact the quality of life (QoL) of affected patients. Chronic venous leg ulcers (CVLUs) are the most severe form of CVD, and several genetic and molecular alterations have been studied in order to understand the progression of CVD towards CLVUs. Chronic inflammation is a key element in CVLUs onset, and recently T helper 17 (Th-17) cells, a subtype of pro-inflammatory T helper (CD4+) cells defined by the production of a cytokine signature of which IL-17 represents the progenitor, seem to be related to several chronic disease. The aim of this study is to evaluate Th17- Gene Expression profile in patients with CVD and CVLUs.

Conditions

Genetic Predisposition to Disease; Inflammation; Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Th17- Gene Expression profile

  Genetic profile in patients with Chronic Venous Disease and in Healthy subjects will be evaluated.

  1 year

Study Arms (2)

Group 1 - Patients with Chronic Venous Disease (CVD)

Patients with CVD at different stages, according to CEAP Classification of Chronic Venous Disorders, will be recruited.

Genetic: Genetic assessment

Group 2 - Healthy subjects without Chronic Venous Disease (CVD)

Voluntary healthy subjects without Chronic Venous Disease (CVD) will be recruited.

Genetic: Genetic assessment

Interventions

Genetic assessment GENETIC

Blood samples will be collected in 3-mL K3 EDTA vacutainer tubes. Peripheral blood mononuclear cells will be isolated via density gradient centrifugation within 2 hours of sample collection. Primary CD4+ T cells will be purified from the peripheral blood lymphocytes using a magnetic cell sorting CD4+ T cell isolation kit, according to the manufacturer's instructions. RNA extraction will be performed. Total RNA will be quantified, and the quality of RNA will be assayed using formaldehyde agarose gel electrophoresis and by determining the 260/280 absorbance ratio. One microgram of total RNA from each sample will be subjected to reverse transcription. One microliter of cDNA will be amplified via real-time PCR and 10 pmol of primers specific to IL23R, IL17, SGK1, RANBP1, TFGB. Real-time PCR assays will be performed in triplicate The specificity of the PCR products will be determined via melting curve analysis.

Group 1 - Patients with Chronic Venous Disease (CVD); Group 2 - Healthy subjects without Chronic Venous Disease (CVD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic venous disease according to CEAP Classification of Chronic Venous Disorders with clinical classes 2-6.

You may qualify if:

• patients with chronic venous disease with CEAP Clinical classes (C) 2-6: C2: varicose veins C3: edema C4: skin changes C5: healed venous ulcers C6: active venous ulcers

You may not qualify if:

• patients with peripheral artery disease
• patients with malignancy

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

University Magna Graecia of Catanzaro

Catanzaro, 880100, Italy

RECRUITING

Related Publications (8)

• Serra R, Ssempijja L, Provenzano M, Andreucci M. Genetic biomarkers in chronic venous disease. Biomark Med. 2020 Feb;14(2):75-80. doi: 10.2217/bmm-2019-0408. Epub 2020 Feb 13. No abstract available.

  PMID: 32053001 BACKGROUND

• Metzinger L, de Franciscis S, Serra R. The Management of Cardiovascular Risk through Epigenetic Biomarkers. Biomed Res Int. 2017;2017:9158572. doi: 10.1155/2017/9158572. Epub 2017 Jul 13.

  PMID: 28785591 BACKGROUND

• de Franciscis S, Metzinger L, Serra R. The Discovery of Novel Genomic, Transcriptomic, and Proteomic Biomarkers in Cardiovascular and Peripheral Vascular Disease: The State of the Art. Biomed Res Int. 2016;2016:7829174. doi: 10.1155/2016/7829174. Epub 2016 May 19.

  PMID: 27298828 BACKGROUND

• Serra R, Buffone G, de Franciscis A, Mastrangelo D, Molinari V, Montemurro R, de Franciscis S. A genetic study of chronic venous insufficiency. Ann Vasc Surg. 2012 Jul;26(5):636-42. doi: 10.1016/j.avsg.2011.11.036.

  PMID: 22664280 BACKGROUND

• Kim JS, Jordan MS. Diversity of IL-17-producing T lymphocytes. Cell Mol Life Sci. 2013 Jul;70(13):2271-90. doi: 10.1007/s00018-012-1163-6. Epub 2012 Oct 4.

  PMID: 23052209 BACKGROUND

• Smith PD. Update on chronic-venous-insufficiency-induced inflammatory processes. Angiology. 2001 Aug;52 Suppl 1:S35-42. doi: 10.1177/0003319701052001s05.

  PMID: 11510595 BACKGROUND

• Moseley TA, Haudenschild DR, Rose L, Reddi AH. Interleukin-17 family and IL-17 receptors. Cytokine Growth Factor Rev. 2003 Apr;14(2):155-74. doi: 10.1016/s1359-6101(03)00002-9.

  PMID: 12651226 BACKGROUND

• Amato R, Dattilo V, Brescia C, D'Antona L, Iuliano R, Trapasso F, Perrotti N, Costa D, Ielapi N, Aiello F, Provenzano M, Bracale UM, Andreucci M, Serra R. Th17-Gene Expression Profile in Patients with Chronic Venous Disease and Venous Ulcers: Genetic Modulations and Preliminary Clinical Evidence. Biomolecules. 2022 Jun 28;12(7):902. doi: 10.3390/biom12070902.

  PMID: 35883458 DERIVED

MeSH Terms

Conditions

Genetic Predisposition to Disease; Inflammation; Varicose Ulcer

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Raffaele Serra, M.D., Ph.D.

  University Magna Graecia of Catanzaro

  STUDY CHAIR

Central Study Contacts

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

CONTACT

+3909613647380; rserra@unicz.it

Study Design

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

Study Record Dates

• First Submitted: November 14, 2021
• First Posted: November 26, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: November 26, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)