Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

NCT03592316 | Completed

• 1 other identifier: 2018021
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Amputation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mortality

  Up to 6 months after surgery

• Major adverse limb event

  Up to 6 months after surgery

• In-hospital morbidity

  Through hospital discharge, approximately 3 days after surgery

• Return to functional independence

  Up to 6 months after surgery

Study Arms (1)

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.

Other: Lower Extremity Amputation Pathway

Interventions

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.

Lower Extremity Amputation Pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years of age diagnosed with peripheral vascular disease and/or diabetes mellitus
• Patients undergoing trans-tibial or trans-femoral amputations

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Community Regional Medical Center

Fresno, California, 93721, United States

Location

Study Officials

• Leigh Ann O'Banion, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 19, 2018
• Study Start: November 14, 2018
• Primary Completion: March 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)