Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities

Clinical Validation of HyperMed OxyVu Tissue Oximeter for Assessing Level of Amputation With Comparison to Other Modalities

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00767923

Acronym

LOA

Enrollment

Registered

2008-10-07

Start date

2008-07-31

Completion date

2010-02-28

Last updated

2009-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia

Keywords

hyperspectral imaging, tissue oxygenation, foot amputation, critical limb ischemia, tissue necrosis

Brief summary

Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Detailed description

The purpose of this clinical study is to correlate tissue oxygenation values measured with a hyperspectral imaging system (OxyVu) to Ankle Brachial Indices (ABI), toe pressures (TBP), and transcutaneous oxygen monitoring (TCOM) in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* 18 to 85 years of age, males and females, varying skin tones, varying racial origins, and with and without diabetes. * Patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Design outcomes

Primary

Measure	Time frame
Assess predictive value for healing by 8 weeks of OxyVu, ABI, TBI and TCOM measured prior to amputation. OxyVu readings for oxyhemoglobin, deoxyhemoglobin and oxygen saturation will be compared to healing potential predicted from ABI, TBI, and TCOM.	8 weeks

Secondary

Measure	Time frame
Collect additional interventions required through review of patient medical records at 12 months	12 Months

Countries

United States

Outcome results