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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower Extremity Amputation Pathway | Experimental | Patients will follow the Lower Extremity Amputation Pathway, which will include pre-operative consultations and earlier progression with physical therapy post-operatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower Extremity Amputation Pathway | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Ann O'Banion, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Regional Medical Center | Fresno | California | 93721 | United States |
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| 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 |