- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01522495
Pilot Study to Determine Percent Tissue Perfusion and Cellular Viability Using SPY Imaging
Pilot Study for: Eye vs. Spy - A Prospective, Randomized Study Evaluating Patient Outcomes With the Use of SPY Imaging During Amputations or Debridements
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Georgetown University Medical Center; Center for Wound Healing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SPY Imaging
SPY Imaging Prior to Amputation or Debridements (50 participants)
|
Intravenous(1X) in conjunction with SPY Imaging (1 arm)
Other Names:
SPY Imaging to assess tissue perfusion
|
NO_INTERVENTION: No SPY Imaging
Amputation or Debridements as Standard of Care (50 participants)
|
|
EXPERIMENTAL: Validation Against Angiogram
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) |
Intravenous(1X) in conjunction with SPY Imaging (1 arm)
Other Names:
SPY Imaging to assess tissue perfusion
|
EXPERIMENTAL: Establishing Normal Values
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)
|
Intravenous(1X) in conjunction with SPY Imaging (1 arm)
Other Names:
SPY Imaging to assess tissue perfusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of percent cellular viability
Time Frame: 6 weeks
|
Determine percent cellular viability (vs.
apoptotic/dead) of cells at demarcation line
|
6 weeks
|
Rate of infection, dehiscence and re-amputation
Time Frame: 20 weeks
|
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
Time Frame: 20 weeks
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eye vs. Spy Pilot Study
- 2011-114 (OTHER: IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Vascular Disease
-
Stanford UniversityTerminatedPAD - Peripheral Arterial Disease | PVD- Peripheral Vascular DiseaseUnited States
-
C. R. BardCromsourceCompletedVascular Diseases, PeripheralGermany, Poland
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Diseases | Peripheral Arterial Occlusive Disease | Peripheral Artery DiseaseUnited States
-
SensomeRecruitingPeripheral Vascular DiseaseBelgium
-
Biotronik, Inc.CompletedPeripheral Vascular Disease | Peripheral Artery DiseaseCanada, United States
-
Biotronik AGBiotronik, Inc.UnknownPeripheral Vascular Disease | Peripheral Artery DiseaseGermany, Belgium, Austria, Switzerland
-
Acotec Scientific Co., LtdRecruitingPeripheral Arterial Disease (PAD) | Peripheral Vascular Disease (PVD)China
-
Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruitingPeripheral Vascular Disease | Peripheral Artery DiseaseUnited States
-
University of MichiganTerminatedPeripheral Vascular Disease | Peripheral Artery DiseaseUnited States
-
Baylor UniversityNational Institute on Aging (NIA)RecruitingArterial Occlusive Diseases | Peripheral Arterial Disease | Atherosclerosis | Vascular Diseases, PeripheralUnited States
Clinical Trials on SPY Imaging, ICG dye (0.2 - 0.5 mg/kg)
-
Cardiox CorporationWithdrawn
-
University of California, San FranciscoBill and Melinda Gates Foundation; Wellcome Trust; Malaria Research and Training... and other collaboratorsCompleted
-
Sichuan Haisco Pharmaceutical Group Co., LtdCompleted
-
The University of Texas Health Science Center,...TerminatedPost Partum DepressionUnited States
-
The First Affiliated Hospital with Nanjing Medical...Wu Jieping Medical FoundationCompleted