Venous InsufficiencyNCT00950378
Non-Invasive Management of Chronic Venous Insufficiency
An observational study of Venous Insufficiency, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Insufficiency
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: CVI subjects will be recruited from University of Utah vascular surgery service.Control group will be recruited from the community.
Who may be able to join
- participants with CVI with CEAP class 4 or higher
- participants with no CVI class 0
Who cannot join
- 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
Show all 9Show fewer
- participants with renal impairment
- pregnancy
- inability or refusal to wear compression stockings prescribed by physician (CVI patients only)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
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.
- Conditions
- Venous Insufficiency
- Keywords
- edema, blood supply, lower legs, venous stasis
- Medical subject headings
- Venous Insufficiency, Edema, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide device development to assess tissue changes associated with chronic venous insufficiency
Measured: two years
Secondary outcomes (1)
To compare device development to existing clinical measurement
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- PhiloMetron, Inc.
- Responsible party
- Sponsor
- Investigators
- Harriet Hopf, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950378
- Sponsor's protocol ID
- 27610
- Other IDs
- 1R43HL092673, University of Utah
- Status last verified
- May 2013
- First submitted
- 30 Jul 2009
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15883226Olin 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.
PubMed 10355863
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Management of Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT00950378
- Acronym / sponsor ID
- 27610
- Conditions
- Venous Insufficiency
- Keywords
- edema, blood supply, lower legs, venous stasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- PhiloMetron, Inc.
- Study start
- Jul 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- CVI subjects will be recruited from University of Utah vascular surgery service.Control group will be recruited from the community.
Key inclusion criteria (2 listed)
- participants with CVI with CEAP class 4 or higher
- participants with no CVI class 0
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To provide device development to assess tissue changes associated with chronic venous insufficiency
Time frame: two years
1 secondary outcome
To compare device development to existing clinical measurement
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
- Background: PubMed 15883226Eberhardt 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.
- Background: PubMed 10355863Olin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harriet Hopf, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Insufficiency, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To provide device development to assess tissue changes associated with chronic venous insufficiency (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00950378, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.