Clinical trial NCT05939271: Lower Extremity Amputations in Persons With Diabetes Mellitus in the Netherlands
Official title: Lower Extremity Amputations in Persons With Diabetes Mellitus in the Netherlands, a Retrospective Study Using an All-payer Claims Database
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lower Extremity Amputations
Diabetes Mellitus
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Isala
name: Innofeet
name: Vektis health care information center
name: National Institute for Public Health and the Environment (RIVM)
First posted: 2023-07-11
Enrollment: 2808
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All persons aged ≥ 18 years, diagnosed with type 1 DM (T1DM) or type 2 DM (T2DM) and matching persons without diabetes.

Brief summary: 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?


Eligibility criteria: 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

Primary outcomes:
measure: - What is the incident amputation rate in persons with and without DM in the Netherlands in the period 2011-2020?
timeFrame: dec 23
Secondary outcomes:
measure: - 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?
timeFrame: dec 23
measure: - What defines persons with DM who need an amputation as compared to matched persons without DM with an amputation?
timeFrame: dec23
measure: - 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?
timeFrame: dec 23
measure: - 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?
timeFrame: dec24
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: L. Rosien
state: Overijssel
Study officials:
References: