Lower Extremity Amputations in Persons With Diabetes Mellitus in the Netherlands

Active, not recruiting

• Conditions: Lower Extremity Amputations; Diabetes Mellitus
• Interventions: Procedure: lower extremity amputation

• Registration Number: NCT05939271
• Lead Sponsor: University Medical Center Groningen

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-02-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Last Update Submitted: 2023-07-03
• Study First Posted: 2023-07-11
• Last Update Posted: 2023-07-11
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2808

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
persons with DM who underwent a lower extremity amputation	lower extremity amputation	-
persons without DM who underwent a lower extremity amputation	lower extremity amputation	-

Primary Outcome Measures

Name	Time	Method
- What is the incident amputation rate in persons with and without DM in the Netherlands in the period 2011-2020?	dec 23

Secondary Outcome Measures

Name	Time	Method
- 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
- 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
- What defines persons with DM who need an amputation as compared to matched persons without DM with an amputation?	dec23
- 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

Trial Locations

Locations (1)

L. Rosien; 🇳🇱 Zwolle, Overijssel, Netherlands