Lower Extremity Amputations in Persons With Diabetes Mellitus in the Netherlands

Sponsor

University Medical Center Groningen (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05939271

Collaborator

Isala (Other), Innofeet (Other), Vektis health care information center (Other), National Institute for Public Health and the Environment (RIVM) (Other)

2,808

Enrollment

Location

Anticipated Duration (Months)

187.4

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Lower Extremity Amputations Diabetes Mellitus	Procedure: lower extremity amputation

Study Design

Study Type:

Observational

Actual Enrollment :

2808 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2022

Actual Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

- 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

- 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	L. Rosien	Zwolle	Overijssel	Netherlands	8025BP

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT05939271

Other Study ID Numbers:

Dude 6-449

First Posted:

Jul 11, 2023

Last Update Posted:

Jul 11, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Study Results

No Results Posted as of Jul 11, 2023