Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

Study Overview
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Brief Summary
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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.

Official Title
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Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

Conditions
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Lower Extremity Amputation

Intervention / Treatment
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* Other: Lower Extremity Amputation Pathway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lower Extremity Amputation Pathway<br>Patients will follow the Lower Extremity Amputation Pathway, which will include pre-operative consultations and earlier progression with physical therapy post-operatively. | Other: Lower Extremity Amputation Pathway<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | The total hospital length of stay for the lower extremity amputation admission | Through hospital discharge, approximately 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality during the follow-up period | Up to 6 months after surgery | 
| Major adverse limb event | Hematoma, infection, ischemia, and/or need for revision of amputation | Up to 6 months after surgery | 
| In-hospital morbidity | Catheter Associated Urinary Tract Infection, Pneumonia, Deep Vein Thrmbosis, and/or Pulmonary Embolism | Through hospital discharge, approximately 3 days after surgery | 
| Return to functional independence | Time to return to functional independence at home | Up to 6 months after surgery |