Lower Extremity Amputations in Persons With Diabetes Mellitus in the Netherlands

Diabetes Mellitus Clinical Trial

Official title:

Lower Extremity Amputations in Persons With Diabetes Mellitus in the Netherlands, a Retrospective Study Using an All-payer Claims Database

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05939271
• Other study ID #: Dude 6-449
• Status: Active, not recruiting
• Start date: September 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2808
• Est. completion date: December 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Procedure:
• lower extremity amputation
persons are defined as having a lower extremity amputation when an operation with removal of an extremity below the hips took place. To identify those people with diabetes who underwent amputation, the following DBC's claims were extracted from the system: "038590; amputation upper leg", "038690; amputation lower leg", "038691; exarticulation of the lower leg", 038790; amputation of the tarsus", "038791; amputation or exarticulation of a toe", "038793; exarticulation of the foot", "038794; Chopart exarticulation, Lisfranc, respectively trans metatarsal amputation". Amputations were categorized into minor (038790, 038791, 038793, 038794) and major (038590, 038690,038691) amputations

Locations

Country	Name	City	State
Netherlands	L. Rosien	Zwolle	Overijssel

Sponsors (5)

Lead Sponsor	Collaborator
University Medical Center Groningen	Innofeet, Isala, National Institute for Public Health and the Environment (RIVM), Vektis health care information center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- What is the incident amputation rate in persons with and without DM in the Netherlands in the period 2011-2020?		dec 23
Secondary	- 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?		dec 23
Secondary	- What defines persons with DM who need an amputation as compared to matched persons without DM with an amputation?		dec23
Secondary	- 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?		dec 23
Secondary	- 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?		dec24