Recruiting

Observational Study

Sponsor:

HyperMed

Code:

NCT00768495

Conditions

Chronic Limb Ischemia

Non-Healing Ulcers

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.

Conditions

Chronic Limb Ischemia

Non-Healing Ulcers

Study ID

NCT00768495

Start date

Oct, 2008

Status verified date

Jun, 2009

Completion date

Dec, 2009

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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.
2. Age group between 50-85
3. Gender - Male or Female
4. Race - all race and ethnicities

Exclusion Criteria:

1. Patients with known cardiac disease - new MI (within 3 months).
2. Patients with hypertension with the systolic BP >200 or diastolic BP>110 on the day of testing
3. Patients on supplemental O2 for chronic obstructive lung disease
4. Bed-ridden subjects - either due to chronic disability or neurological problems

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

One Cohort

Central Contacts and Locations

Central contacts

Locations

Cardiac, Vascular & Thoracic Surgery Associates

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Dipankar Mukherjee, MD

703-280-5858

More Information

Sponsor

HyperMed

Last update posted

Jun 4, 2009

Last verified

Jun, 2009

Keywords

  • revascularization
  • claudication
  • hyperspectral
  • oxygenation
  • limb ischemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HyperMed on 2009-06-04.