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

Completed

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT03978715
• Lead Sponsor: 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.

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).

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Study Start: 2021-04-14
• Primary Completion: 2022-10-07
• Study Completion: 2022-10-07
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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.

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Exclusion Criteria

• not fitting inclusion criteria.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of lower limb complications	One year	The number of lower limb complications per participant.

Trial Locations

Locations (1)

UT Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States