Status:
COMPLETED
Pilot Study to Determine Percent Tissue Perfusion and Cellular Viability Using SPY Imaging
Lead Sponsor:
Georgetown University
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 uncl...
Detailed Description
Peripheral arterial disease (PAD), like other more central macrovascular diseases, is common in diabetes. PAD can lead to critical limb ischemia, either alone or when combined with an injury like a fo...
Eligibility Criteria
Inclusion
- Subject is at least 18 years or older.
- Subject has PVD demonstrated by angiogram.
- Subject is undergoing the first amputation/debridement after vascular intervention, if intervention is/was warranted.
- Subject has had a vascular consult and/or intervention.
- Subject must sign an IRB approved informed consent.
- Subject is willing and able to complete required follow up.
Exclusion
- Subject has no evidence of PVD
- Subject's wound presents with a malignancy in the wound bed.
- Subject has liver disease (Previously diagnosed with liver disease or elevated AST, ALT, Alk Phos, or Bilirubin labs within 30 days of procedure).
- Subject has a disorder or situation that the investigator believes will interfere with study compliance.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01522495
Start Date
April 1 2013
End Date
December 1 2019
Last Update
March 11 2020
Active Locations (1)
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1
Georgetown University Medical Center; Center for Wound Healing
Washington D.C., District of Columbia, United States, 20007