Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

Completed · Not applicable

Conditions studied: Lower Extremity Amputation

In brief

The LEAP protocol is a prospective cohort study of dysvascular patients designed to determine whether implementation of a multi-disciplinary lower extremity amputation protocol in the peri-operative period can shorten post-operative length of stay in patients undergoing trans-tibial or trans-femoral amputations. A consecutive sample of patients diagnosed with peripheral vascular disease and/or diabetes requiring major lower extremity amputation will be enrolled in the study and compared to retrospective controls.

Key facts

Study ID

NCT03592316

Run by

University of California, San Francisco

People needed

11

Starts

2018-11-14

Expected to finish

2020-12-31

Last updated by the study team

2021-02-12

Who can join

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

You may qualify if…

• Patients >18 years of age diagnosed with peripheral vascular disease and/or diabetes mellitus
• Patients undergoing trans-tibial or trans-femoral amputations

You may not qualify if…

• Patients undergoing amputation for trauma, malignancy, or necrotizing fasciitis with no dysvascular diagnosis
• Patients who have previously undergone an amputation
• Patients who were unable to function independently prior to admission
• Patients admitted to the ICU prior to surgery
• Attending surgeon does not approve of the patient being enrolled
• Prisoners
• Pregnant women

Where it is running

• Community Regional Medical Center — Fresno, California, United States

Full record on ClinicalTrials.gov

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