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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05939271
Enrollment
2808
Registered
2023-07-11
Start date
2022-09-01
Completion date
2023-12-01
Last updated
2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Lower Extremity Amputations

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?

Interventions

PROCEDURElower 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

Sponsors

Isala
CollaboratorOTHER
Innofeet
CollaboratorUNKNOWN
Vektis health care information center
CollaboratorUNKNOWN
National Institute for Public Health and the Environment (RIVM)
CollaboratorOTHER_GOV
University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime 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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026