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Completed

NCT Number: NCT03592316

Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

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.

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Key information

Conditions

Lower Extremity Amputation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Regional Medical Center

Fresno, California, 93721, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 19, 2018
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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