Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients
February 10, 2021 updated by: University of California, San Francisco
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Fresno, California, United States, 93721
- Community Regional Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lower Extremity Amputation Pathway
Patients will follow the Lower Extremity Amputation Pathway, which will include pre-operative consultations and earlier progression with physical therapy post-operatively.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital length of stay
Time Frame: Through hospital discharge, approximately 3 days after surgery
|
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
Time Frame: Up to 6 months after surgery
|
Mortality during the follow-up period
|
Up to 6 months after surgery
|
|
Major adverse limb event
Time Frame: Up to 6 months after surgery
|
Hematoma, infection, ischemia, and/or need for revision of amputation
|
Up to 6 months after surgery
|
|
In-hospital morbidity
Time Frame: Through hospital discharge, approximately 3 days after surgery
|
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 Frame: Up to 6 months after surgery
|
Time to return to functional independence at home
|
Up to 6 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Leigh Ann O'Banion, MD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 14, 2018
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
July 10, 2018
First Submitted That Met QC Criteria
July 10, 2018
First Posted (Actual)
July 19, 2018
Study Record Updates
Last Update Posted (Actual)
February 12, 2021
Last Update Submitted That Met QC Criteria
February 10, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2018021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.