NCT05939271

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,808

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

July 3, 2023

Last Update Submit

July 3, 2023

Conditions

Lower Extremity AmputationsDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • - What is the incident amputation rate in persons with and without DM in the Netherlands in the period 2011-2020?

    dec 23

Secondary Outcomes (4)

  • - 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

Study Arms (3)

persons with DM who underwent a lower extremity amputation

Procedure: lower extremity amputation

persons with DM who did not underwent a lower extremity amputation

persons without DM who underwent a lower extremity amputation

Procedure: lower extremity amputation

Interventions

lower extremity amputationPROCEDURE

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 underwent a lower extremity amputationpersons without DM who underwent a lower extremity amputation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All persons aged ≥ 18 years, diagnosed with type 1 DM (T1DM) or type 2 DM (T2DM) and matching persons without diabetes.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

L. Rosien

Zwolle, Overijssel, 8025BP, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 11, 2023

Study Start

September 1, 2022

Primary Completion

February 1, 2023

Study Completion

December 1, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

NL(1)