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

NCT01522495 | Completed DMC

• 2 other identifiers: Eye vs. Spy Pilot Study2011-114
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (3)

• Determination of percent cellular viability

  Determine percent cellular viability (vs. apoptotic/dead) of cells at demarcation line

  6 weeks

• Rate of infection, dehiscence and re-amputation

  Rate of infection, dehiscence and re-amputation in patients undergoing SPY imaging

  20 weeks

• Number of debridements, revisional surgeries and days of stay in hospital

  The endpoint for evaluation will be the number of revisional surgeries and number of days of stay in hospital within 20 weeks of the first procedure.

  20 weeks

Study Arms (4)

SPY Imaging

EXPERIMENTAL

SPY Imaging Prior to Amputation or Debridements (50 participants)

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

No SPY Imaging

NO INTERVENTION

Amputation or Debridements as Standard of Care (50 participants)

Validation Against Angiogram

EXPERIMENTAL

Patients who are scheduled to undergo an angiogram will also receive ICG angiography (SPY). This will occur at specific time points: 1.) before the angiogram/intervention is performed 2.) immediately after the angiogram/intervention is performed 3.) 5-7 days after angiogram/intervention 4.) 21-30 days after angiogram/intervention. (30 participants)

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

Establishing Normal Values

EXPERIMENTAL

To establish baseline lower extremity perfusion in non-PVD patients. Patients requiring an angiogram for other vascular processes unrelated to the lower extremity will be recruited into this study. ICG angiography (SPY) of the lower extremity will be performed at the time of the angiogram. (30 Participants)

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

Interventions

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

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

Also known as: Indocyanine Green, IC-GREEN

Establishing Normal Values; SPY Imaging; Validation Against Angiogram

SPY Imaging DEVICE

SPY Imaging to assess tissue perfusion

Establishing Normal Values; SPY Imaging; Validation Against Angiogram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Medical Center; Center for Wound Healing

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christopher E Attinger, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Division of The Center for Wound Healing

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: January 31, 2012
• Study Start: April 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

US (1)