Chronic Limb IschemiaCLI-Pre/PostNCT00768495
Hyperspectral Imaging Pre and Post Endovascular Intervention
An observational study of Chronic Limb Ischemia and Non-Healing Ulcers, run by HyperMed at 1 site in United States.
Trial summary
This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Chronic Limb Ischemia, Non-Healing Ulcers
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2009
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have chronic limb ischemia and present with the symptoms of claudication, rest pain or having minor non-healing ulcers or gangrene (Rutherford category 1 to 6) who also require percutaneous endovascular revascularization.
Who may be able to join
- Patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization.
- Age group between 50-85
- Gender - Male or Female
- Race - all race and ethnicities
Who cannot join
- Patients with known cardiac disease - new MI (within 3 months).
- Patients with hypertension with the systolic BP >200 or diastolic BP>110 on the day of testing
- Patients on supplemental O2 for chronic obstructive lung disease
- Bed-ridden subjects - either due to chronic disability or neurological problems
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cardiac, Vascular & Thoracic Surgery Associates
Falls Church, Virginia, 22042
Dipankar Mukherjee, MD, 703-280-5858 ext. 1111
About this study
Official title: Evaluation of the Success of Endovascular Peripheral Revascularization for the Treatment of Chronic Limb Ischemia by Measuring OxyHb and DeoxyHb Using a New Hyperspectral Imaging Device (OxyVu).
This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.
Read the detailed description
This will be a nonrandomized, nonblinded, prospective observational study to correlate the results obtained with the traditional measures of success of endovascular revascularization of peripheral arteries for the treatment of chronic limb ischemia; i.e., ABPI, PVR with oxyhemoglobin (OxyHb) and deoxyhemoglobin (DeoxyHb) measurements obtained with a new imaging device manufactured by HyperMed Inc (OxyVu) that uses hyperspectral technology.
- Conditions
- Chronic Limb Ischemia, Non-Healing Ulcers
- Keywords
- revascularization, claudication, hyperspectral, oxygenation, limb ischemia
- Medical subject headings
- Intermittent Claudication
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 |
|---|---|---|
| One Cohort | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Limb IschemiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HyperMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)
- Investigators
- Kevin Schomacker, PhD, Study director, HyperMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768495
- Sponsor's protocol ID
- 2008-023
- Acronym
- CLI-Pre/Post
- Status last verified
- Jun 2009
- First submitted
- 6 Oct 2008
- Last updated
- 4 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ostchega Y, Paulose-Ram R, Dillon CF, Gu Q, Hughes JP. Prevalence of peripheral arterial disease and risk factors in persons aged 60 and older: data from the National Health and Nutrition Examination Survey 1999-2004. J Am Geriatr Soc. 2007 Apr;55(4):583-9. doi: 10.1111/j.1532-5415.2007.01123.x.
PubMed 17397438White C. Clinical practice. Intermittent claudication. N Engl J Med. 2007 Mar 22;356(12):1241-50. doi: 10.1056/NEJMcp064483. No abstract available.
PubMed 17377162Yao ST. Haemodynamic studies in peripheral arterial disease. Br J Surg. 1970 Oct;57(10):761-6. doi: 10.1002/bjs.1800571016. No abstract available.
PubMed 5476754Begelman SM, Jaff MR. Noninvasive diagnostic strategies for peripheral arterial disease. Cleve Clin J Med. 2006 Oct;73 Suppl 4:S22-9. doi: 10.3949/ccjm.73.suppl_4.s22.
PubMed 17385388Raines JK, Darling RC, Buth J, Brewster DC, Austen WG. Vascular laboratory criteria for the management of peripheral vascular disease of the lower extremities. Surgery. 1976 Jan;79(1):21-9.
PubMed 1246689
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Success of Endovascular Peripheral Revascularization for the Treatment of Chronic Limb Ischemia by Measuring OxyHb and DeoxyHb Using a New Hyperspectral Imaging Device (OxyVu).
- ClinicalTrials.gov ID
- NCT00768495
- Acronym / sponsor ID
- CLI-Pre/Post / 2008-023
- Conditions
- Chronic Limb Ischemia, Non-Healing Ulcers
- Keywords
- revascularization, claudication, hyperspectral, oxygenation, limb ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- HyperMedIndustry (pharma, biotech, devices)
- Collaborators
- Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 8 Oct 2008 (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.
This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.
Detailed description
This will be a nonrandomized, nonblinded, prospective observational study to correlate the results obtained with the traditional measures of success of endovascular revascularization of peripheral arteries for the treatment of chronic limb ischemia; i.e., ABPI, PVR with oxyhemoglobin (OxyHb) and deoxyhemoglobin (DeoxyHb) measurements obtained with a new imaging device manufactured by HyperMed Inc (OxyVu) that uses hyperspectral technology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One Cohort | – | – |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have chronic limb ischemia and present with the symptoms of claudication, rest pain or having minor non-healing ulcers or gangrene (Rutherford category 1 to 6) who also require percutaneous endovascular revascularization.
Key inclusion criteria (4 listed)
- Patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization.
- Age group between 50-85
- Gender - Male or Female
- Race - all race and ethnicities
Key exclusion criteria (4 listed)
- Patients with known cardiac disease - new MI (within 3 months).
- Patients with hypertension with the systolic BP >200 or diastolic BP>110 on the day of testing
- Patients on supplemental O2 for chronic obstructive lung disease
- Bed-ridden subjects - either due to chronic disability or neurological problems
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2009.
- Background: PubMed 17397438Ostchega Y, Paulose-Ram R, Dillon CF, Gu Q, Hughes JP. Prevalence of peripheral arterial disease and risk factors in persons aged 60 and older: data from the National Health and Nutrition Examination Survey 1999-2004. J Am Geriatr Soc. 2007 Apr;55(4):583-9. doi: 10.1111/j.1532-5415.2007.01123.x.
- Background: PubMed 17377162White C. Clinical practice. Intermittent claudication. N Engl J Med. 2007 Mar 22;356(12):1241-50. doi: 10.1056/NEJMcp064483. No abstract available.
- Background: PubMed 5476754Yao ST. Haemodynamic studies in peripheral arterial disease. Br J Surg. 1970 Oct;57(10):761-6. doi: 10.1002/bjs.1800571016. No abstract available.
- Background: PubMed 17385388Begelman SM, Jaff MR. Noninvasive diagnostic strategies for peripheral arterial disease. Cleve Clin J Med. 2006 Oct;73 Suppl 4:S22-9. doi: 10.3949/ccjm.73.suppl_4.s22.
- Background: PubMed 1246689Raines JK, Darling RC, Buth J, Brewster DC, Austen WG. Vascular laboratory criteria for the management of peripheral vascular disease of the lower extremities. Surgery. 1976 Jan;79(1):21-9.
- Sponsor and OxyVu technology websiteLink provided by the sponsor.
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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.
Kevin Schomacker, PhD study director
HyperMed
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 Chronic Limb Ischemia and Non-Healing Ulcers, run by HyperMed 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Jun 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin Scomacker, PhD (781-229-5900, kschomacker@hypermed-inc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00768495, which also lists 5 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 4 Jun 2009.