Peripheral Vascular DiseaseNCT01522495
Pilot Study to Determine Percent Tissue Perfusion and Cellular Viability Using SPY Imaging
A study testing SPY Imaging, ICG dye (0.2 - 0.5 mg/kg) and SPY Imaging in people with Peripheral Vascular Disease, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- SPY Imaging, ICG dye (0.2 - 0.5 mg/kg) and SPY Imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center; Center for Wound Healing
Washington D.C., District of Columbia, 20007
About this study
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
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.
Read the 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.
- Conditions
- Peripheral Vascular Disease
- Being tested
- SPY Imaging, ICG dye (0.2 - 0.5 mg/kg), SPY Imaging
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPY Imaging, ICG dye (0.2 - 0.5 mg/kg)Device
Also called Indocyanine Green, IC-GREEN
Intravenous(1X) in conjunction with SPY Imaging (1 arm)
SPY ImagingDevice
SPY Imaging to assess tissue perfusion
| Study group | Role | What they receive |
|---|---|---|
| SPY Imaging | Experimental | SPY Imaging Prior to Amputation or Debridements (50 participants) Receives: 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) Receives: 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) Receives: Device: SPY Imaging, ICG dye (0.2 - 0.5 mg/kg); Device: SPY Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of percent cellular viability
Determine percent cellular viability (vs. apoptotic/dead) of cells at demarcation line
Measured: 6 weeks
Rate of infection, dehiscence and re-amputation
Rate of infection, dehiscence and re-amputation in patients undergoing SPY imaging
Measured: 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.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startApr 2013
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Attinger, M.D., Georgetown University
- Investigators
- Christopher E Attinger, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522495
- Sponsor's protocol ID
- Eye vs. Spy Pilot Study
- Other IDs
- 2011-114
- Status last verified
- Mar 2020
- First submitted
- 27 Jan 2012
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01522495
- Acronym / sponsor ID
- Eye vs. Spy Pilot Study
- Conditions
- Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SPY Imaging | Experimental | Device: SPY Imaging, ICG dye (0.2 - 0.5 mg/kg), Device: SPY ImagingSPY Imaging Prior to Amputation or Debridements (50 participants) |
| No SPY Imaging | No intervention | –Amputation or Debridements as Standard of Care (50 participants) |
| Validation Against Angiogram | Experimental | Device: SPY Imaging, ICG dye (0.2 - 0.5 mg/kg), Device: SPY ImagingPatients 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) |
| Establishing Normal Values | Experimental | Device: SPY Imaging, ICG dye (0.2 - 0.5 mg/kg), Device: SPY ImagingTo 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPY Imaging, ICG dye (0.2 - 0.5 mg/kg)Also: Indocyanine Green, IC-GREENIntravenous(1X) in conjunction with SPY Imaging (1 arm) | Device | Establishing Normal Values, SPY Imaging, Validation Against Angiogram |
| SPY ImagingSPY Imaging to assess tissue perfusion | Device | Establishing Normal Values, SPY Imaging, Validation Against Angiogram |
Primary outcome
Determination of percent cellular viability
Time frame: 6 weeks
Determine percent cellular viability (vs. apoptotic/dead) of cells at demarcation line
Rate of infection, dehiscence and re-amputation
Time frame: 20 weeks
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher E Attinger, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPY Imaging, ICG dye (0.2 - 0.5 mg/kg) and SPY Imaging in people with Peripheral Vascular Disease, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of percent cellular viability (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.