Pilot Study to Determine Percent Tissue Perfusion and Cellular Viability Using SPY Imaging
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | April 2013 |
| End Date: | December 2019 |
Pilot Study for: Eye vs. Spy - A Prospective, Randomized Study Evaluating Patient Outcomes With the Use of SPY Imaging During Amputations or Debridements
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.
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.
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.
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.
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.
We found this trial at
1
site
Washington, District of Columbia 20007
Principal Investigator: Christopher E Attinger, MD
Phone: 202-444-0793
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