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
|Condition or disease||Intervention/treatment|
|Diabetic Foot Ulcer||Other: No intervention-retrospective study|
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 Type :||Observational|
|Estimated Enrollment :||1500 participants|
|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|
- Other: No intervention-retrospective study
This is a retrospective study. No interventionOther Name: Retrospective study
- number of lower limb complications [ Time Frame: One year ]The number of lower limb complications per participant.
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
|United States, Texas|
|UT Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Lawrence Lavery, DPM MPH||UT Southwestern Medical Center|