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Trial record 1 of 4 for:    18308683 [PUBMED-IDS]
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The Effect of Implementing a Limb Loss Prevention Program on Amputation Rates

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ClinicalTrials.gov Identifier: NCT03978715
Recruitment Status : Active, not recruiting
First Posted : June 7, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Larry Lavery, University of Texas Southwestern Medical Center

Brief Summary:
The investigators plan to do a retrospective chart review on patients admitted to Parkland Hospital with diabetic foot infections, ulcers, and bone injuries from 2005 (5 years prior to the start of the diabetic limb preservation team) to present day. The investigators will collect information on demographics, medical/surgical history, social history, medications, laboratory results, peripheral arterial disease, wound severity, and treatment factors such as type of antibiotics, off-loading, debridement, wound healing, surgery interventions, complications, recurrence, and history and physical characteristics and exam from inpatient and outpatient encounters. This will be identified by current procedural terminology (CPT) codes for foot and leg amputations, and lower extremity revascularization procedures. Clinic visits will be identified to podiatry/foot wound, vascular surgery, invasive cardiology, general surgery, and physical therapy wound care in addition to inpatient encounters of these patients to determine the full scope of care received and to compare resources utilization before and after implementation of the diabetic limb preservation team.

Condition or disease Intervention/treatment
Diabetic Foot Ulcer Other: No intervention-retrospective study

Detailed Description:

This will be a retrospective chart review on patients admitted to Parkland Hospital with diabetic foot infections, ulcers, and bone injuries from 2005 (5 years prior to the start of the diabetic limb preservation team) to present day. The investigators will collect information from medical records on demographics, medical/surgical history, social history, medications, laboratory results, peripheral arterial disease, wound severity, and treatment factors such as type of antibiotics, off-loading, debridement, wound healing, surgery interventions, complications, recurrence, and history and physical characteristics and exam from inpatient and outpatient encounters. This will be identified by current procedural terminology (CPT) codes for foot and leg amputations, and lower extremity revascularization procedures. Clinic visits will be identified to podiatry/foot wound, vascular surgery, invasive cardiology, general surgery, and physical therapy wound care in addition to inpatient encounters of these patients to determine the full scope of care received and to compare resources utilization before and after implementation of the diabetic limb preservation team. Study records will by a study identification number that will be assigned to the subject as soon as data collection is completed on each individual chart.

Non-parametric statistical analyses comparing individuals within each group and also differences between the groups will be performed using IBM SPSS Statistics version 25 (IBM Corporation, Armonk, New York).


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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: The Effect of Implementing a Limb Loss Prevention Program on Amputation Rates
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No intervention-retrospective study
    This is a retrospective study. No intervention
    Other Name: Retrospective study


Primary Outcome Measures :
  1. number of lower limb complications [ Time Frame: One year ]
    The number of lower limb complications per participant.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients admitted to Parkland Hospital with diabetic foot infections, ulcers, and bone injuries from 2005 (5 years prior to the start of the diabetic limb preservation team) to present day.
Criteria

Inclusion Criteria:

  • patients admitted to Parkland Hospital with diabetic foot infections, ulcers, and bone injuries from 2005 (5 years prior to the start of the diabetic limb preservation team) to present day.

Exclusion Criteria:

  • not fitting inclusion criteria.

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): NCT03978715


Locations
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United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Lawrence Lavery, DPM MPH UT Southwestern Medical Center

Publications:

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Responsible Party: Larry Lavery, Professor and Director of Research, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03978715     History of Changes
Other Study ID Numbers: 2018-0158
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
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
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases