Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

University of California, San Francisco11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lower Extremity Amputation

Interventions

Lower Extremity Amputation PathwayOTHER

Pre-operatively: Subjects will meet with social work/case management, physical therapy, anesthesiology, and the prosthetist for the following: discuss expectations and rehabilitation; pain control options and consideration for epidural or nerve block; prosthetic treatment and care timeline. Post-operatively: Physical therapy will begin on post-op day 1 with increasing complexity through post-op day 3. On post-op day 3 the wound will be examined by the surgeon and subjects will be cleared for discharge. Quality of life surveys will be given at several time points during post-operative care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Community Regional Medical Center

Fresno, California, United States

Outcomes

Primary Outcomes

Hospital length of stay

The total hospital length of stay for the lower extremity amputation admission

Time frame: Through hospital discharge, approximately 3 days after surgery

Secondary Outcomes

Mortality

Mortality during the follow-up period

Time frame: Up to 6 months after surgery

Major adverse limb event

Hematoma, infection, ischemia, and/or need for revision of amputation

Time frame: Up to 6 months after surgery

In-hospital morbidity

Catheter Associated Urinary Tract Infection, Pneumonia, Deep Vein Thrmbosis, and/or Pulmonary Embolism

Time frame: Through hospital discharge, approximately 3 days after surgery

Return to functional independence

Time to return to functional independence at home

Time frame: Up to 6 months after surgery

Data from ClinicalTrials.gov

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