Wound HealingNCT02440295
Pilot Study to Assess the Use of Spy Elite for Assessment of Amputation Healing
An observational study of Wound Healing and Lower Extremity Amputation, run by Corewell Health West at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the use of the SPY Elite System to assess real-time tissue perfusion of lower extremity amputation sites and to develop parameters to predict healing of amputations at the time of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing, Lower Extremity Amputation, Above Knee Amputation
- What is being tested?
- Lower Extremity Amputation, SPY Elite Imaging System and Indocyaine Green
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2016
- Phase
- Observational
- 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
Study population: Currently there are no proven, reliable, objective tests to predict wound healing for amputations. Successful wound healing relies heavily on perfusion of the tissue flaps during amputation, which may already be compromised in peripheral vascular patients. Amputation failure results in repeat hospitalizations, surgeries and prolonged immobility for patients. The financial burden for patients and hospitals are significant, as is the psychological and emotional burden for patients facing repeat amputation. Failure rates for BKA and AKA amputations are 10% and 7% respectively. In elderly patients, readmission rates are as high as 27% with a mortality rate of 9% at 30 days.1 With improved ability to identify amputation sites at risk for wound complication and failure, we hope to decrease the need for readmission and repeat surgery.
Who may be able to join
- All patients >= 18 years of age requiring Below Knee Amputation (BKA) or Above Knee Amputation (AKA) cared for by the vascular surgery service will be assessed for eligibility.
Who cannot join
- Subjects with a history of allergies to iodides or iodinated contrast agents, pregnant or nursing women, subjects who are unable to provide consent, and prisoners will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
About this study
The purpose of the study is to evaluate the use of the SPY Elite System to assess real-time tissue perfusion of lower extremity amputation sites and to develop parameters to predict healing of amputations at the time of surgery.
This is a pilot study to see if the Spy Elite System is capable of recording accurate measurements on amputation sites to allow some correlation to healing. If this study shows promise for the device, the investigators would plan a larger study in which the data would be assessed in the operating room at time of acquisition and revision performed if needed based on the findings.
Read the detailed description
The pilot study is a prospective cohort study of consented subjects who require below knee or above knee amputation. The study will start with 18 subjects to assess proof of concept. If a correlation is identified, then a new proposal will be submitted with a larger cohort.
Our hypothesis is that the Spy Elite System can help identify areas of poor tissue perfusion at the time of lower extremity amputation, and predict future potential wound healing complications.
Primary outcome variables include wound healing at 30 days, and intra-operative imaging of amputation sites using the Spy Elite System. Secondary outcome variables include level of amputation, 30-day wound healing complications, readmission rate, need for revision, and subject demographics and co-morbidities.
Subjects who agree to participation will undergo the amputations in the operating suite as per routine. The Spy Elite System will be implemented after final wound closure and prior to dressing placement. A single injection of 10 mg of Indocyanine Green will be administered, followed by 10 ml bolus of normal saline as per manufacturer IFU and recommendations (Attachments B, C, D). Recording from the Spy Elite Device will be saved for analysis. Also, a digital photograph of the surgical wound will be saved for comparison. No changes in operative management based on Spy Elite System will take place in this study.
At subjects routine 30-day follow up appointment, wounds will be assessed for complications, a digital photograph of the incision will be saved, and secondary endpoints will be obtained.
Possible correlations between perfusion values from the Spy Elite System recording and wound healing will be analyzed by the Investigators. The values will not be known until after the photos are taken and the investigators compare ischemic areas to normal areas based on the collected photographs.
- Being tested
- Lower Extremity Amputation, SPY Elite Imaging System, Indocyaine Green
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Extremity AmputationProcedure or surgery
Also called Above Knee Amputation, Below Knee Amputation
SPY Elite Imaging SystemDevice
Also called SPY Elite Device, SPY Elite Kit
The SPY Elite Imaging System is an adjunctive tool that can be used to assess tissue perfusion in real-time and provides surgeons with information that may change their operative plan before leaving the operating room. (http://novadaq.com/products/spy-elite) The system is comprised of two components, the first is the Spy Elite Kit, which is a single-use package containing one 25 mg vial of indocyanine green, one 10 ml vial of sterile Water for injection, and one SPY Elite sterile drape. The second component to the system is the SPY Elite Device which contains a near-infrared light source that illuminates the fluorescent agent within the tissues, an HD video camera captures the intensity of fluorescent marker in real-time, and software that allows the user to capture relative and absolute perfusion values within the surgical field.
Indocyaine GreenDrug
Also called ICG
Indocyaine Green (ICG) is a non-nephrotoxic fluorescent imaging agent with a half-life of 2.5-3 minutes that is administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Lower Extremity Amputations | All patients >= 18 years of age requiring Below Knee Amputation (BKA) or Above Knee Amputation (AKA) cared for by the Spectrum Health vascular surgery service will be assessed for eligibility.
Subjects with a history of allergies to iodides or iodinated contrast agents, pregnant or nursing women, subjects who are unable to provide consent, and prisoners will be excluded. Eighteen subjects will be enrolled in the pilot study. No special population subjects will be enrolled. Receives: Procedure: Lower Extremity Amputation; Device: SPY Elite Imaging System; Drug: Indocyaine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing Post Lower Extremity Amputation
The primary outcome variable includes wound healing at 30 days and intra-operative imaging of amputation sites using the SPY Elite System.
Measured: 30 days post
Secondary outcomes (6)
Level of Amputation
The secondary outcome variables include level of amputation.
Measured: Intra-operative
Wound Healing
The secondary outcome variables include 30-day wound healing complications.
Measured: 30 days Post Lower Extremity Amputation
Readmission Rates
The secondary outcome variables include readmission rates.
Measured: 30 days Post Lower Extremity Amputation
Lower Extremity Amputation Revision
The secondary outcome variables include need for revision.
Measured: 30 days Post Lower Extremity Amputation
Subject Demographics
The secondary outcome variables include subject demographics
Measured: Participants will be followed for the duration of the hospital stay and 30 days post lower extremity amputation
Co-morbidities
The secondary outcome variables include co-morbidites.
Measured: Participants will be followed for the duration of the hospital stay and 30 days post lower extremity amputation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Collaborators
- Novadaq Technologies ULC, now a part of Stryker
- Responsible party
- Principal investigator, Robert Cuff, Corewell Health West
- Investigators
- Robert F. Cuff, MD, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440295
- Sponsor's protocol ID
- 2014-253
- Status last verified
- Sep 2023
- First submitted
- 27 Mar 2015
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Vogel TR, Petroski GF, Kruse RL. Impact of amputation level and comorbidities on functional status of nursing home residents after lower extremity amputation. J Vasc Surg. 2014 May;59(5):1323-30.e1. doi: 10.1016/j.jvs.2013.11.076. Epub 2014 Jan 7.
PubMed 24406089Losken A, Zenn MR, Hammel JA, Walsh MW, Carlson GW. Assessment of zonal perfusion using intraoperative angiography during abdominal flap breast reconstruction. Plast Reconstr Surg. 2012 Apr;129(4):618e-624e. doi: 10.1097/PRS.0b013e3182450b16.
PubMed 22456376Pineda C., Shelton A., Raju N., Welton M. Use of Introperative Fluorescence vascular angiography to assess intestinal perfusion in the creation of intestinal anastomoses. Tech Colo. 2011;15:215-253.
Lepow B, Perry D, Armstrong D. The Use of SPY Intra-operative Vascular Angiography as a Predictor of Wound Healing. Podiatry Mgmt. 2011 Aug; 141-148.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Use of Spy Elite for Assessment of Amputation Healing
- ClinicalTrials.gov ID
- NCT02440295
- Acronym / sponsor ID
- 2014-253
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Collaborators
- Novadaq Technologies ULC, now a part of Stryker
- Study start
- May 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 May 2015 (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.
The purpose of the study is to evaluate the use of the SPY Elite System to assess real-time tissue perfusion of lower extremity amputation sites and to develop parameters to predict healing of amputations at the time of surgery.
This is a pilot study to see if the Spy Elite System is capable of recording accurate measurements on amputation sites to allow some correlation to healing. If this study shows promise for the device, the investigators would plan a larger study in which the data would be assessed in the operating room at time of acquisition and revision performed if needed based on the findings.
Detailed description
The pilot study is a prospective cohort study of consented subjects who require below knee or above knee amputation. The study will start with 18 subjects to assess proof of concept. If a correlation is identified, then a new proposal will be submitted with a larger cohort.
Our hypothesis is that the Spy Elite System can help identify areas of poor tissue perfusion at the time of lower extremity amputation, and predict future potential wound healing complications.
Primary outcome variables include wound healing at 30 days, and intra-operative imaging of amputation sites using the Spy Elite System. Secondary outcome variables include level of amputation, 30-day wound healing complications, readmission rate, need for revision, and subject demographics and co-morbidities.
Subjects who agree to participation will undergo the amputations in the operating suite as per routine. The Spy Elite System will be implemented after final wound closure and prior to dressing placement. A single injection of 10 mg of Indocyanine Green will be administered, followed by 10 ml bolus of normal saline as per manufacturer IFU and recommendations (Attachments B, C, D). Recording from the Spy Elite Device will be saved for analysis. Also, a digital photograph of the surgical wound will be saved for comparison. No changes in operative management based on Spy Elite System will take place in this study.
At subjects routine 30-day follow up appointment, wounds will be assessed for complications, a digital photograph of the incision will be saved, and secondary endpoints will be obtained.
Possible correlations between perfusion values from the Spy Elite System recording and wound healing will be analyzed by the Investigators. The values will not be known until after the photos are taken and the investigators compare ischemic areas to normal areas based on the collected photographs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower Extremity Amputations | – | Procedure: Lower Extremity Amputation, Device: SPY Elite Imaging System, Drug: Indocyaine GreenAll patients >= 18 years of age requiring Below Knee Amputation (BKA) or Above Knee Amputation (AKA) cared for by the Spectrum Health vascular surgery service will be assessed for eligibility. Subjects with a history of allergies to iodides or iodinated contrast agents, pregnant or nursing women, subjects who are unable to provide consent, and prisoners will be excluded. Eighteen subjects will be enrolled in the pilot study. No special population subjects will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Currently there are no proven, reliable, objective tests to predict wound healing for amputations. Successful wound healing relies heavily on perfusion of the tissue flaps during amputation, which may already be compromised in peripheral vascular patients. Amputation failure results in repeat hospitalizations, surgeries and prolonged immobility for patients. The financial burden for patients and hospitals are significant, as is the psychological and emotional burden for patients facing repeat amputation. Failure rates for BKA and AKA amputations are 10% and 7% respectively. In elderly patients, readmission rates are as high as 27% with a mortality rate of 9% at 30 days.1 With improved ability to identify amputation sites at risk for wound complication and failure, we hope to decrease the need for readmission and repeat surgery.
Key inclusion criteria (1 listed)
- All patients >= 18 years of age requiring Below Knee Amputation (BKA) or Above Knee Amputation (AKA) cared for by the vascular surgery service will be assessed for eligibility.
Key exclusion criteria (1 listed)
- Subjects with a history of allergies to iodides or iodinated contrast agents, pregnant or nursing women, subjects who are unable to provide consent, and prisoners will be excluded.
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 |
|---|---|---|
| Lower Extremity AmputationAlso: Above Knee Amputation, Below Knee Amputation | Procedure or surgery | Lower Extremity Amputations |
| SPY Elite Imaging SystemAlso: SPY Elite Device, SPY Elite KitThe SPY Elite Imaging System is an adjunctive tool that can be used to assess tissue perfusion in real-time and provides surgeons with information that may change their operative plan before leaving the operating room. (http://novadaq.com/products/spy-elite) The system is comprised of two components, the first is the Spy Elite Kit, which is a single-use package containing one 25 mg vial of indocyanine green, one 10 ml vial of sterile Water for injection, and one SPY Elite sterile drape. The second component to the system is the SPY Elite Device which contains a near-infrared light source that illuminates the fluorescent agent within the tissues, an HD video camera captures the intensity of fluorescent marker in real-time, and software that allows the user to capture relative and absolute perfusion values within the surgical field. | Device | Lower Extremity Amputations |
| Indocyaine GreenAlso: ICGIndocyaine Green (ICG) is a non-nephrotoxic fluorescent imaging agent with a half-life of 2.5-3 minutes that is administered intravenously. | Drug | Lower Extremity Amputations |
Primary outcome
Wound Healing Post Lower Extremity Amputation
Time frame: 30 days post
The primary outcome variable includes wound healing at 30 days and intra-operative imaging of amputation sites using the SPY Elite System.
6 secondary outcomes
Level of Amputation
Time frame: Intra-operative
Wound Healing
Time frame: 30 days Post Lower Extremity Amputation
Readmission Rates
Time frame: 30 days Post Lower Extremity Amputation
Lower Extremity Amputation Revision
Time frame: 30 days Post Lower Extremity Amputation
Subject Demographics
Time frame: Participants will be followed for the duration of the hospital stay and 30 days post lower extremity amputation
Co-morbidities
Time frame: Participants will be followed for the duration of the hospital stay and 30 days post lower extremity amputation
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 28 Sep 2023.
- Background: PubMed 24406089Vogel TR, Petroski GF, Kruse RL. Impact of amputation level and comorbidities on functional status of nursing home residents after lower extremity amputation. J Vasc Surg. 2014 May;59(5):1323-30.e1. doi: 10.1016/j.jvs.2013.11.076. Epub 2014 Jan 7.
- Background: PubMed 22456376Losken A, Zenn MR, Hammel JA, Walsh MW, Carlson GW. Assessment of zonal perfusion using intraoperative angiography during abdominal flap breast reconstruction. Plast Reconstr Surg. 2012 Apr;129(4):618e-624e. doi: 10.1097/PRS.0b013e3182450b16.
- BackgroundPineda C., Shelton A., Raju N., Welton M. Use of Introperative Fluorescence vascular angiography to assess intestinal perfusion in the creation of intestinal anastomoses. Tech Colo. 2011;15:215-253.
- BackgroundLepow B, Perry D, Armstrong D. The Use of SPY Intra-operative Vascular Angiography as a Predictor of Wound Healing. Podiatry Mgmt. 2011 Aug; 141-148.
- Spy Elite System OverviewLink provided by the sponsor.
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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.
Robert F. Cuff, MD principal investigator
Corewell Health West
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Healing and Lower Extremity Amputation, run by Corewell Health West 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 1 inclusion and 1 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 28 Sep 2023. 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?
Wound Healing Post Lower Extremity Amputation (time frame: 30 days post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440295, which also lists 4 linked publications.
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 28 Sep 2023.