Non-Invasive Management of Chronic Venous Insufficiency
3 other identifiers
observational
10
1 country
1
Brief Summary
The purpose of this study is:
- item one to use two new non-invasive technologies to evaluate scarring and swelling associated with chronic venous insufficiency. The study hypothesis: \- item one non-invasive technologies can provide a tool for assessing risk of ulcer development based on the tissue edema and alteration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2009
Typical duration for all trials
1 active site
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
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 29, 2013
May 1, 2013
3.1 years
July 30, 2009
May 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To provide device development to assess tissue changes associated with chronic venous insufficiency
two years
Secondary Outcomes (1)
To compare device development to existing clinical measurement
two years
Study Arms (2)
CVI
Varicose veins, varicose veins with leg swelling, venous stasis skin color changes, no open ulcers
No treatment
Subjects with no venous disease CEAP (clinical etiology antomy pathophysiology)Class 0
Eligibility Criteria
CVI subjects will be recruited from University of Utah vascular surgery service.Control group will be recruited from the community.
You may qualify if:
- participants with CVI with CEAP class 4 or higher
- participants with no CVI class 0
You may not qualify if:
- open ulcers or lower extremity amputation
- diabetics with HbA1C greater than 7.0
- arterial occlusive disease
- BMI greater than 35
- any connective tissue disorder (lipodermatosclerosis and fibrosis)
- participants with metallic prosthesis or implants
- participants with renal impairment
- pregnancy
- inability or refusal to wear compression stockings prescribed by physician (CVI patients only)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- PhiloMetron, Inc.collaborator
Study Sites (1)
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
Related Publications (2)
Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. doi: 10.1161/01.CIR.0000164199.72440.08. No abstract available.
PMID: 15883226BACKGROUNDOlin JW, Beusterien KM, Childs MB, Seavey C, McHugh L, Griffiths RI. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med. 1999;4(1):1-7. doi: 10.1177/1358836X9900400101.
PMID: 10355863BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harriet Hopf, MD
University of Utah
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2009
First Posted
July 31, 2009
Study Start
July 1, 2009
Primary Completion
August 1, 2012
Study Completion
December 1, 2012
Last Updated
May 29, 2013
Record last verified: 2013-05