Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

NCT ID: NCT03592316

Last Updated: 2021-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Lower Extremity Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lower Extremity Amputation Pathway

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leigh Ann O'Banion, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Community Regional Medical Center

Fresno, California, United States

Site Status

Countries

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United States

Other Identifiers

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2018021

Identifier Type: -

Identifier Source: org_study_id

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