Lower Extremity Amputations in Persons With Diabetes Mellitus in the Netherlands

University Medical Center Groningen (UMCG)

Status: Active, not recruiting

Conditions: Lower Extremity Amputations; Diabetes Mellitus

Treatments: Procedure: lower extremity amputation

Study type: Observational

Funder types: Other

Identifiers

NCT05939271

Dude 6-449

Details and patient eligibility

About

This is a retrospective, observational study based on an all-payer claims database (APCD) in the period 2011 to 2020) managed by the Vektis Health Care Information Center. In 2006, Vektis was established by Dutch health insurers aiming to combine and interpret reimbursement data and enable the main players in the Dutch healthcare market to base decisions and policy on reliable, essential, and timely information. Vektis receives data from all Dutch health care insurers. The APCD covers health care claims of 99.9% of the Dutch population. This study is part of the DUtch Diabetes Estimates (DUDE) initiative. We aim to perform different predefined analyses with the available data:

• What is the incident amputation rate in persons with and without DM in the Netherlands in the period 2011-2020?
• What defines persons with DM who need an amputation as compared to matched persons with DM but without an amputation in 2016, both in aspects of health care use and costs?
• What defines persons with DM who need an amputation as compared to matched persons without DM with an amputation?
• Does Social Economic Status (SES) play a role in amputation incidence and level, or on longer term outcome in persons with DM in the Netherlands?
• Does the presence of a formal multidisciplinary foot clinic / team in a hospital make a difference, especially when comparing previous and actual macrovascular complication rates?

Enrollment: 2,808 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All persons aged ≥ 18 years, diagnosed with type 1 DM (T1DM) or type 2 DM (T2DM) identified in the Vektis data met the inclusion criteria

Exclusion criteria

• none

Trial design

2,808 participants in 3 patient groups

persons with DM who underwent a lower extremity amputation

Treatment:

Procedure: lower extremity amputation

persons with DM who did not underwent a lower extremity amputation

persons without DM who underwent a lower extremity amputation

Treatment:

Procedure: lower extremity amputation