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Multi-spectral Imaging to Assess Wounds in Peripheral Vascular Disease Patients

NCT02624674 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-12-08

No results posted yet for this study

Summary

Peripheral vascular disease (PVD) is a common disease of impaired blood flow resulting in the compromised tissue perfusion of lower limbs. PAD patients can experience pain, diminished exercise capacity, and tissue loss, with some ultimately requiring amputation. The economic burden of PVD is significant. In the United States alone, PVD accounts for over $20 billion in annual healthcare related costs.

The demand for the development of an effective method to characterize the viability of PVD wounds has resulted in the emergence of several innovative techniques. Commonly used diagnostic methods are ankle-brachial index (ABI), pulse volume recordings, duplex ultrasonography, venous plethysmography, Transcutaneous oxygen tension (TcPO2), toe pressures, angiography by X-ray, computed tomography, and magnetic resonance imaging. Currently, angiography remains the diagnostic gold standard. However, many of these techniques lack the ability to triage and adequately determine the viability of the wound. In addition, there remains a need for effective triage technologies to help clinicians decide whether surgical management is needed. Early determination of surgical versus conservative management may help to improve patient functional outcomes, reduce mortality rates, and prevent limb amputation.

Near-infrared point spectroscopy (NIRS) is a non-invasively technology with recent applications in PVD wound assessment. To date, studies have demonstrated the validity of NIRS technology in patients with peripheral arterial disease. NIRS measures flow, concentration, and oxygenation of hemoglobin in arterioles, capillaries, and venules several centimeters deep in tissue. The MSID is an evolution of existing NIRS imaging devices and has become a portable and functional commercial device produced by KENT imaging (Calgary, Canada). Using this new and clinically applicable NIRS technology designed for assessing wound perfusion and oxygenation, this study seeks to adequately identify viable from non-viable wounds and to rapidly determine indication for vascular interventions. This technology is well-suited for use in a wound patient population as the measurements times are short and can quickly be used at the patient bed side. As such, this project intends to apply NIR technology to quickly assess PVD in the investigators' patient population.

Conditions

  • Peripheral Vascular Disease Patient

Interventions

DEVICE

Multi-spectral Imaging Device (MSID)

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02624674 on ClinicalTrials.gov