ClinicalTrials.Veeva

Menu

Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia

V

Vioptix

Status

Terminated

Conditions

Peripheral Arterial Disease

Treatments

Device: ODISsey Tissue Oximeter

Study type

Observational

Funder types

Industry

Identifiers

NCT00224328
VIO-UHN-001

Details and patient eligibility

About

Near-infrared spectroscopy can be used to determine the relative oxygen saturation in tissues up to 2cm below the skin. It has been investigated, with success, in cerebral, gastrointestinal, and muscle tissue, and shows promise in numerous indications involving tissue ischemia. In the current study, we propose to examine one hundred patients requiring either bypass or angioplasty due to chronic critical limb ischemia resulting from peripheral arterial disease. We intend to challenge patients before and after the intervention, using either an inflated blood pressure cuff or toe raises, to determine if oxygen saturation recovery time in the affected limb is correlated with symptom resolution (i.e. treatment success). Near-infrared spectroscopy will be performed using the ODISsey tissue oximeter developed by ViOptix, Inc. The proposed study will take approximately one year to complete enrolment, and has a follow-up period of 6 months post-intervention.

Study Hypothesis: Knowledge of tissue oxygen saturation enhances clinical decision making in patients with chronic critical limb ischemia.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • >= 18 years old
  • PAD
  • Chronic Critical Limb Ischemia
  • requiring surgical intervention
  • able to give informed consent

Exclusion criteria

  • emergent/urgent requirement for surgical intervention
  • requiring surgical intervention due to acute traumatic injury

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems