Lower Extremity Amputation
Conditions
Brief summary
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.
Interventions
OTHERLower Extremity Amputation Pathway
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.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay | Through hospital discharge, approximately 3 days after surgery | The total hospital length of stay for the lower extremity amputation admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Up to 6 months after surgery | Mortality during the follow-up period |
| Major adverse limb event | Up to 6 months after surgery | Hematoma, infection, ischemia, and/or need for revision of amputation |
| In-hospital morbidity | Through hospital discharge, approximately 3 days after surgery | Catheter Associated Urinary Tract Infection, Pneumonia, Deep Vein Thrmbosis, and/or Pulmonary Embolism |
| Return to functional independence | Up to 6 months after surgery | Time to return to functional independence at home |
Countries
United States
Outcome results
None listed