NCT02440295

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.6 years

First QC Date

March 27, 2015

Last Update Submit

September 26, 2023

Conditions

Wound HealingLower Extremity AmputationAbove Knee AmputationBelow Knee Amputation

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days post

Secondary Outcomes (6)

  • Level of Amputation

    Intra-operative

  • Wound Healing

    30 days Post Lower Extremity Amputation

  • Readmission Rates

    30 days Post Lower Extremity Amputation

  • Lower Extremity Amputation Revision

    30 days Post Lower Extremity Amputation

  • Subject Demographics

    Participants will be followed for the duration of the hospital stay and 30 days post lower extremity amputation

  • +1 more secondary outcomes

Study Arms (1)

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.

Procedure: Lower Extremity AmputationDevice: SPY Elite Imaging SystemDrug: Indocyaine Green

Interventions

Lower Extremity AmputationPROCEDURE
Also known as: Above Knee Amputation, Below Knee Amputation
Lower Extremity Amputations
SPY Elite Imaging SystemDEVICE

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.

Also known as: SPY Elite Device, SPY Elite Kit
Lower Extremity Amputations
Indocyaine GreenDRUG

Indocyaine Green (ICG) is a non-nephrotoxic fluorescent imaging agent with a half-life of 2.5-3 minutes that is administered intravenously.

Also known as: ICG
Lower Extremity Amputations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (4)

  • 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.

    PMID: 24406089BACKGROUND

  • Losken 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.

    PMID: 22456376BACKGROUND

  • Pineda 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.

    BACKGROUND

  • 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.

    BACKGROUND

Related Links

Study Officials

  • Robert F. Cuff, MD

    Corewell Health West

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director for Integrated Vascular Surgery Residency and Vascular Surgery Fellowship

Study Record Dates

First Submitted

March 27, 2015

First Posted

May 12, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

US(1)