Clinical trial NCT03978715: The Effect of Implementing a Limb Loss Prevention Program on Amputation Rates
Official title: The Effect of Implementing a Limb Loss Prevention Program on Amputation Rates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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).

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.

Primary outcomes:
measure: number of lower limb complications
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Lawrence Lavery, DPM MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013 Apr;36(4):1033-46. doi: 10.2337/dc12-2625. Epub 2013 Mar 6.
citation: American Diabetes Association. Economic costs of diabetes in the U.S. In 2007. Diabetes Care. 2008 Mar;31(3):596-615. doi: 10.2337/dc08-9017.
citation: Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28. doi: 10.1001/jama.293.2.217.
citation: Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Ragnarson Tennvall G, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, van Baal J, van Merode F, Schaper N. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007 Jan;50(1):18-25. doi: 10.1007/s00125-006-0491-1. Epub 2006 Nov 9.
citation: Lavery LA, Peters EJ, Armstrong DG, Wendel CS, Murdoch DP, Lipsky BA. Risk factors for developing osteomyelitis in patients with diabetic foot wounds. Diabetes Res Clin Pract. 2009 Mar;83(3):347-52. doi: 10.1016/j.diabres.2008.11.030. Epub 2008 Dec 30.
citation: Wukich DK, Hobizal KB, Sambenedetto TL, Kirby K, Rosario BL. Outcomes of Osteomyelitis in Patients Hospitalized With Diabetic Foot Infections. Foot Ankle Int. 2016 Dec;37(12):1285-1291. doi: 10.1177/1071100716664364. Epub 2016 Aug 22.
citation: Mutluoglu M, Sivrioglu AK, Eroglu M, Uzun G, Turhan V, Ay H, Lipsky BA. The implications of the presence of osteomyelitis on outcomes of infected diabetic foot wounds. Scand J Infect Dis. 2013 Jul;45(7):497-503. doi: 10.3109/00365548.2013.765589. Epub 2013 Feb 5.
citation: Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJ. Diabetic foot syndrome: evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-Hispanic whites from a diabetes disease management cohort. Diabetes Care. 2003 May;26(5):1435-8. doi: 10.2337/diacare.26.5.1435.
citation: Lavery LA, Lavery DC, Hunt NA, La Fontaine J, Ndip A, Boulton AJ. Amputations and foot-related hospitalisations disproportionately affect dialysis patients. Int Wound J. 2015 Oct;12(5):523-6. doi: 10.1111/iwj.12146. Epub 2013 Sep 19.