Pilot Study to Assess the Use of Spy Elite for Assessment of Amputation Healing

Completed

Conditions studied: Wound Healing, Lower Extremity Amputation, Above Knee Amputation, Below Knee Amputation

In brief

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.

Key facts

Study ID

NCT02440295

Run by

Corewell Health West

People needed

18

Starts

2015-05-01

Expected to finish

2016-12-01

Last updated by the study team

2023-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Spectrum Health Hospitals — Grand Rapids, Michigan, United States

Full record on ClinicalTrials.gov

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