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Clinical Trials/NCT03978715
NCT03978715
Completed
Not Applicable

The Effect of Implementing a Limb Loss Prevention Program on Amputation Rates

University of Texas Southwestern Medical Center1 site in 1 country3,000 target enrollmentApril 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Foot Ulcer
Sponsor
University of Texas Southwestern Medical Center
Enrollment
3000
Locations
1
Primary Endpoint
number of lower limb complications
Status
Completed
Last Updated
2 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
April 14, 2021
End Date
October 7, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Larry Lavery

Professor and Director of Research

University of Texas Southwestern Medical Center

Eligibility 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.

Outcomes

Primary Outcomes

number of lower limb complications

Time Frame: One year

The number of lower limb complications per participant.

Study Sites (1)

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