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Hyperspectral Imaging to Assess and Predict Diabetic Foot Ulcers

NCT00617916 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 256

Last updated 2009-06-04

No results posted yet for this study

Summary

This study is designed to test a prototype imaging instrument that relies on Medical HyperSpectral Imaging (MHSI) technology for the assessment and prediction of diabetic foot ulceration and wound healing. The imaging system utilizes the biomarkers of oxyhemoglobin (oxyHb) and deoxyhemoglobin (deoxyHb), in the upper layers of skin on the foot as: a metric for assessing wound healing, a reflection of microvascular disease, and determining tissue at risk for forming new ulcers. MHSI results will also be compare with ABI and TcPO2 measurements.

Conditions

  • Diabetic Foot Ulcers

Sponsors & Collaborators

  • HyperMed

    lead INDUSTRY

  • The Cleveland Clinic

    collaborator OTHER

  • Olive View-UCLA Education & Research Institute

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

Principal Investigators

  • Brian L Davis, PhD · The Cleveland Clinic

  • Aksone Nouvong, DPM · Olive View-UCLA Education & Research Institute

  • Emile Mohler, MD · University of Pennsylvania

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00617916 on ClinicalTrials.gov