Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05134597
Other study ID # E.R.ALL.2018.42
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date March 31, 2022

Study information

Verified date November 2021
Source University of Catanzaro
Contact Raffaele Serra, M.D.,Ph.D.
Phone +3909613647380
Email rserra@unicz.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Chronic Venous Disease (CVD) is a widespread clinical condition widely spread in the western countries, with a prevalence ranging from 10% in adults younger than 30 years of age to nearly 80% for individuals >70 years of age. CVD clinical manifestations vary from mild clinical signs, including varicose veins, to more advanced and severe signs such as chronic venous leg ulcers (CVLUs) which significantly impact the quality of life (QoL) of affected patients. Several genetic and molecular alterations have been studied so far to understand the onset, progression, and complications of CVD, including Chronic Venous Insufficiency (CVI) states in which CVLUs may develop. The appearance of CVLUs is generally preceded by skin changes of the lower limbs such as lipodermatosclerosis, that is a chronic inflammatory condition due to CVI, characterised by an inflammatory skin condition. This pathological event leads to subcutaneous fibrosis and hardening of the affected skin, resulting in tissue hypoxia essential for venous ulceration.Gene expression profile studies, present in the current literature, allow us to hypothesize several mechanisms underlying the development of CVLU, highlighting a wide variety of genetic-molecular interconnections. Nevertheless, none to date is able to provide a genetic and cellular model linking the pathogenetic events that lead to the onset of CVLU or the progression of these lesions.T helper 17 (Th-17) cells are a subtype of pro-inflammatory T helper (CD4+) cells defined by the production of a cytokine signature of which IL-17 represents the progenitor. The development and differentiation and expansion of Th-17 depends on differentiation factors (TGF- β ), growth factors (IL-23/IL23R) and several transcription factors (ROR-γt, STAT3 ). Interestingly, the Th-17 axis has been implicated in several autoimmune diseases including rheumatoid arthritis, multiple sclerosis, ulcerative colitis, Crohn's disease, psoriasis, and autoimmune encephalitis among others. In addition, an increasingly strong role of the Th-17 axis in tumor drug resistance and in the progression and radicalization of HIV infection is recently emerging. Our study aims at evaluation Th17- Gene Expression profile in patients with CVD and CVLUs.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date March 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - patients with peripheral artery disease - patients with malignancy

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Genetic assessment
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.

Locations

Country Name City State
Italy University Magna Graecia of Catanzaro Catanzaro

Sponsors (1)

Lead Sponsor Collaborator
University of Catanzaro

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Smith PD. Update on chronic-venous-insufficiency-induced inflammatory processes. Angiology. 2001 Aug;52 Suppl 1:S35-42. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Th17- Gene Expression profile Genetic profile in patients with Chronic Venous Disease and in Healthy subjects will be evaluated. 1 year
See also
  Status Clinical Trial Phase
Completed NCT03995979 - Inflammation and Protein Restriction N/A
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT03577223 - Egg Effects on the Immunomodulatory Properties of HDL N/A
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT05529693 - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population N/A
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Recruiting NCT04543877 - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study Early Phase 1
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Completed NCT06065241 - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals. N/A
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Not yet recruiting NCT06134076 - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota N/A
Not yet recruiting NCT05910489 - Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect