Lower Extremity Amputations in Persons With Diabetes Mellitus in the Netherlands

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

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus; Lower Extremity Amputations
• Intervention / Treatment: Procedure: lower extremity amputation

• Study Type: Observational
• Enrollment (Actual): 2808

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025BP
      • L. Rosien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
persons with DM who underwent a lower extremity amputation	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
persons with DM who did not underwent a lower extremity amputation
persons without DM who underwent a lower extremity amputation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
- 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

Outcome Measure	Time Frame
- 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
- 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
- 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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: National Institute for Public Health and the Environment (RIVM); Isala; Innofeet; Vektis health care information center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: Dude 6-449

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets are not publicly available, as formal consent from the Dutch health insurers is needed to gain access to these files. Data could made available from Vektis Health Care Information Center upon reasonable request and with formal consent of the Dutch health insurers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No