Pilot Study to Determine Percent Tissue Perfusion and Cellular Viability Using SPY Imaging
Completed · Not applicable
Conditions studied: Peripheral Vascular Disease
In brief
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.
Key facts
- Study ID
- NCT01522495
- Run by
- Georgetown University
- People needed
- 31
- Starts
- 2013-04-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2020-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Georgetown University Medical Center; Center for Wound Healing — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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