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

This study has suspended participant recruitment.
(Device update in progress)
Sponsor:
Information provided by (Responsible Party):
Christopher Attinger, M.D., Georgetown University
ClinicalTrials.gov Identifier:
NCT01522495
First received: January 27, 2012
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Peripheral Vascular Disease
Device: SPY Imaging, ICG dye (0.2 - 0.5 mg/kg)
Device: SPY Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pilot Study for: Eye vs. Spy - A Prospective, Randomized Study Evaluating Patient Outcomes With the Use of SPY Imaging During Amputations or Debridements

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Determination of percent cellular viability [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Determine percent cellular viability (vs. apoptotic/dead) of cells at demarcation line

  • Rate of infection, dehiscence and re-amputation [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Rate of infection, dehiscence and re-amputation in patients undergoing SPY imaging

  • Number of debridements, revisional surgeries and days of stay in hospital [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPY Imaging
SPY Imaging (1 arm)
Device: SPY Imaging, ICG dye (0.2 - 0.5 mg/kg)
Intravenous(1X) in conjunction with SPY Imaging (1 arm)
Other Name: Indocyanine Green, IC-GREEN
Device: SPY Imaging
SPY Imaging to assess tissue perfusion

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 foot ulcer. The diabetic foot ulceration requires adequate circulation to heal; if the circulation is impaired such that the tissue oxygen demand exceeds supply, critical limb ischemia ensues, placing the limb at risk.

Most often, patients with critical limb ischemia, undergo multiple debridements in the operating room as well as vascular procedures, prior to reaching a viable level of amputation. This increases the patients' co-morbidities from repetitive exposure to anesthesia. Each debridement may be removing viable tissue and decreasing the length of the eventual amputation. Additionally, intraoperatively, the viability of the skin edges is a subjective assessment based on the surgeon's experience. That judgement can be inaccurate in 10-20% of cases and lad to reoperation. With the use of the SPY imaging system, a better assessment of not only macrovascularity, but also microvascularity of the tissues is able to be evaluated objectively. This helps identify the tissues that are underperfused.

The investigators are unaware of any literature evaluating the use of SPY imaging in the lower extremities intraoperatively during amputations or debridements. There are many studies published for the use of this technology during ophthalmic procedures , cerebral aneurismal repair, cardiac surgery and breast reconstruction. In cardiac surgery, the use of ICG based imaging has proven to be helpful in assessing the quality of bypass grafts and eliminating the need for radiography or catheter insertion (Reuthebuch et al., 2004). In ophthalmic procedures, ICG angiography has been fundamental in identifying many microvascular pathologies (Slakter, Yannuzzi, Guyer, Sorenson, & Orlock, 1995). Furthermore, neurosurgeons have found that the use of ICG angiography is far more superior than DS angiography in identifying small vessels . As it has already been proven to be a good adjunct intraoperatively to visualize microvasculature, the investigators would like to apply this to the lower extremities. Identifying underperfused tissues intraoperatively can help the surgeon objectively decide an appropriate level of amputation/debridement to effectively minimize the number of revisional surgeries. Also, there are no studies that comprehensively evaluate and compare the effectiveness of other modalities that also attempt to assess vascularity with the SPY imaging system. The information gained could be pivotal and help to gain more insight in patients with difficult to heal wounds, especially in the presence of PVD.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522495

Locations
United States, District of Columbia
Georgetown University Medical Center; Center for Wound Healing
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Christopher E Attinger, MD Georgetown University
Study Director: Paul J Kim, DPM Georgetown University
  More Information

No publications provided

Responsible Party: Christopher Attinger, M.D., Chief of the Division of The Center for Wound Healing, Georgetown University
ClinicalTrials.gov Identifier: NCT01522495     History of Changes
Other Study ID Numbers: Eye vs. Spy Pilot Study, 2011-114
Study First Received: January 27, 2012
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board (IRB; Georgetown University)

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 18, 2014