Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

Lower Extremity Amputation Clinical Trial

Official title:

Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592316
• Other study ID #: 2018021
• Status: Completed
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Extremity Amputation

Intervention

Other:
• Lower 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.

Locations

Country	Name	City	State
United States	Community Regional Medical Center	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Mortality during the follow-up period	Up to 6 months after surgery
Secondary	Major adverse limb event	Hematoma, infection, ischemia, and/or need for revision of amputation	Up to 6 months after surgery
Secondary	In-hospital morbidity	Catheter Associated Urinary Tract Infection, Pneumonia, Deep Vein Thrmbosis, and/or Pulmonary Embolism	Through hospital discharge, approximately 3 days after surgery
Secondary	Return to functional independence	Time to return to functional independence at home	Up to 6 months after surgery