NCT01993914

Brief Summary

The etiologies of varicose veins and the progression to more serious forms of chronic venous disease and identification of appropriate diagnostic tests to better aid patient management by identifying individuals who may benefit from more aggressive treatment and/ or prophylactic measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

3.8 years

First QC Date

November 19, 2013

Last Update Submit

November 14, 2014

Conditions

Varicose VeinsMTHFRVenous DiseaseThrombosis

Outcome Measures

Primary Outcomes (1)

  • Prevalence of MTHFR mutation between patients

    Determine whether the prevalence of the MTHFR mutation differs between patient with varicose veins compared to controls and with or without superficial vein thrombosis.

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the Elite Laser Vein Center, representative of the ethnic population of Los Angeles, CA, estimated as 40% Non Hispanic White, 40% Hispanic, 10% African American, 10% Asian.

You may qualify if:

  • Age 18 or over
  • No venous disease (N=30); or C2-C3 venous disease (N=30); or C4-C6 venous disease (N=30)

You may not qualify if:

  • Pregnancy
  • Cancer
  • Chronic obstructive pulmonary disease (COPD)
  • Any systemic inflammatory disease
  • Any of the following within the previous 30 days:
  • Trauma
  • Any surgery
  • Periods of prolonged inactivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Elite Laser Vein Center

Los Angeles, California, 90025, United States

Location

Related Publications (10)

  • Sverdlova AM, Bubnova NA, Baranovskaya SS, Vasina VI, Avitisjan AO, Schwartz EI. Prevalence of the methylenetetrahydrofolate reductase (MTHFR) C677T mutation in patients with varicose veins of lower limbs. Mol Genet Metab. 1998 Jan;63(1):35-6. doi: 10.1006/mgme.1997.2638. No abstract available.

    PMID: 9538515BACKGROUND

  • Wilmanns C, Casey A, Schinzel H, Walter PK. Superficial thrombophlebitis in varicose vein disease: the particular role of methylenetetrahydrofolate reductase. Phlebology. 2011 Jun;26(4):135-9. doi: 10.1258/phleb.2009.009075. Epub 2010 Sep 29.

    PMID: 20881312BACKGROUND

  • Krijnen RM, de Boer EM, Bruynzeel DP. Epidemiology of venous disorders in the general and occupational populations. Epidemiol Rev. 1997;19(2):294-309. doi: 10.1093/oxfordjournals.epirev.a017959. No abstract available.

    PMID: 9494789BACKGROUND

  • Campbell B. Varicose veins and their management. BMJ. 2006 Aug 5;333(7562):287-92. doi: 10.1136/bmj.333.7562.287. No abstract available.

    PMID: 16888305BACKGROUND

  • Jorgensen JO, Hanel KC, Morgan AM, Hunt JM. The incidence of deep venous thrombosis in patients with superficial thrombophlebitis of the lower limbs. J Vasc Surg. 1993 Jul;18(1):70-3. doi: 10.1067/mva.1993.42072.

    PMID: 8326661BACKGROUND

  • Ascer E, Lorensen E, Pollina RM, Gennaro M. Preliminary results of a nonoperative approach to saphenofemoral junction thrombophlebitis. J Vasc Surg. 1995 Nov;22(5):616-21. doi: 10.1016/s0741-5214(95)70049-8.

    PMID: 7494365BACKGROUND

  • Chengelis DL, Bendick PJ, Glover JL, Brown OW, Ranval TJ. Progression of superficial venous thrombosis to deep vein thrombosis. J Vasc Surg. 1996 Nov;24(5):745-9. doi: 10.1016/s0741-5214(96)70007-1.

    PMID: 8918318BACKGROUND

  • Leon L, Giannoukas AD, Dodd D, Chan P, Labropoulos N. Clinical significance of superficial vein thrombosis. Eur J Vasc Endovasc Surg. 2005 Jan;29(1):10-7. doi: 10.1016/j.ejvs.2004.09.021.

    PMID: 15570265BACKGROUND

  • Binder B, Lackner HK, Salmhofer W, Kroemer S, Custovic J, Hofmann-Wellenhof R. Association between superficial vein thrombosis and deep vein thrombosis of the lower extremities. Arch Dermatol. 2009 Jul;145(7):753-7. doi: 10.1001/archdermatol.2009.123.

    PMID: 19620555BACKGROUND

  • Caprini JA, Goldshteyn S, Glase CJ, Hathaway K. Thrombophilia testing in patients with venous thrombosis. Eur J Vasc Endovasc Surg. 2005 Nov;30(5):550-5. doi: 10.1016/j.ejvs.2005.05.034. Epub 2005 Aug 1.

    PMID: 16055356BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and serum

MeSH Terms

Conditions

Varicose VeinsThrombosis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesEmbolism and Thrombosis

Study Officials

  • Michael Richman, MD,FACS,FCCP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

February 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 17, 2014

Record last verified: 2014-11

Locations

US(1)