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Lower Extremity Amputations in Persons With Diabetes Mellitus in the Netherlands

NCT05939271 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2808

Last updated 2023-07-11

No results posted yet for this study

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?

Conditions

Interventions

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

Sponsors & Collaborators

  • Isala

    collaborator OTHER

  • Innofeet

    collaborator UNKNOWN

  • Vektis health care information center

    collaborator UNKNOWN

  • National Institute for Public Health and the Environment (RIVM)

    collaborator OTHER_GOV

  • University Medical Center Groningen

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-02-01
Completion
2023-12-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05939271 on ClinicalTrials.gov