Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

University of California San Francisco (UCSF)

Status: Completed

Conditions: Lower Extremity Amputation

Treatments: Other: Lower Extremity Amputation Pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT03592316

2018021

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Lower Extremity Amputation Pathway

Experimental group

Description:

Patients will follow the Lower Extremity Amputation Pathway, which will include pre-operative consultations and earlier progression with physical therapy post-operatively.

Treatment:

Other: Lower Extremity Amputation Pathway