Clinical Trials Directory

Trials / Completed

CompletedNCT03978715

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

Status
Completed
Phase
Study type
Observational
Enrollment
3,000 (actual)
Sponsor
University of Texas Southwestern Medical Center · Academic / Other
Sex
All
Age
18 Years – 89 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
OTHERNo intervention-retrospective studyThis is a retrospective study. No intervention

Timeline

Start date
2021-04-14
Primary completion
2022-10-07
Completion
2022-10-07
First posted
2019-06-07
Last updated
2023-07-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03978715. Inclusion in this directory is not an endorsement.