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Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03592316
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lower Extremity Amputation Other: Lower Extremity Amputation Pathway Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

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.
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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Up to 6 months after surgery ]
    Mortality during the follow-up period

  2. Major adverse limb event [ Time Frame: Up to 6 months after surgery ]
    Hematoma, infection, ischemia, and/or need for revision of amputation

  3. 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

  4. Return to functional independence [ Time Frame: Up to 6 months after surgery ]
    Time to return to functional independence at home



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592316


Contacts
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Contact: Rachel Dirks, PhD 559-459-4029 rdirks@communitymedical.org

Locations
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United States, California
Community Regional Medical Center Recruiting
Fresno, California, United States, 93721
Contact: Rachel Dirks, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Leigh Ann O'Banion, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03592316    
Other Study ID Numbers: 2018021
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No