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Pilot Study to Determine Percent Tissue Perfusion and Cellular Viability Using SPY Imaging

NCT01522495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-03-11

No results posted yet for this study

Summary

Little is known about chronic wound microenvironments, especially in peripheral vascular disease (PVD) and diabetic patients. At the demarcation line, the percentage of viable cells and tissue is unclear. A means to determine cell viability, particularly discerning an apoptotic or necrotic cell pathway would indicate where the line of demarcation should be drawn. The information generated would better predict clinical outcome using SPY Imaging. Cellular studies are needed to successfully confirm a clear line of demarcation to eliminate surgeon subjectivity.

Conditions

  • Peripheral Vascular Disease

Interventions

DEVICE

SPY Imaging, ICG dye (0.2 - 0.5 mg/kg)

Intravenous(1X) in conjunction with SPY Imaging (1 arm)

DEVICE

SPY Imaging

SPY Imaging to assess tissue perfusion

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Principal Investigators

  • Christopher E Attinger, MD · Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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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 NCT01522495 on ClinicalTrials.gov