Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

Not Applicable

Completed

• Conditions: Lower Extremity Amputation

• Registration Number: NCT03592316
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-19
• Study Start: 2018-11-14
• Primary Completion: 2020-03-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Community Regional Medical Center; 🇺🇸 Fresno, California, United States