COROPIEDIAB: Impact of COVID-19 Infection and Confinement on Diabetic Ulcer Management and Amputation Risk

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Completed
CT.gov ID
NCT04891276
Collaborator
(none)
3,300,000
1
5.9
558020.8

Study Details

Study Description

Brief Summary

In the context of the COVID-19 pandemic, a number of factors, including the lockdown that was imposed to limit the spread of infection, the fear of being contaminated during hospital consultations and the difficulty in accessing general practitioners may have led to delays in the referral of patients to facilities specialized in the management of diabetic ulcers. Since the beginning of the coronavirus pandemic and during the first lockdown, we observed a clear decrease in hospitalizations and consultations for diabetic ulcers. Patients who had regular follow-up for the management of their diabetic ulcers cancelled their scheduled appointments for fear of being contaminated in the hospital. It is feared that the current epidemic context has favored the delay of referral of patients with diabetic ulcers to specialized facilities, with consequences on the prognosis of these patients and the risk of lower limb amputation.

In this context, this project aims to evaluate the impact of confinement on emergency hospitalizations for foot wounds and the effects on the risk of amputation during the lockdown and the three months following the end of the lockdown.

Our hypothesis is that the lockdown led to a decrease in hospitalizations for foot wounds, resulting in a delay in the management of these patients, and potentially leading to an increase in the number of amputations in the three months following the end of the lockdown.

In parallel, we will also study the impact of confinement on deferrable hospitalizations (glycemic imbalance, assessment of diabetic complications...) or theoretically non-deferrable (diabetic comas, ketoacidosis, diagnosis of type 1 diabetes, acute coronary syndrome, stroke...) of diabetes mellitus. This will allow us to evaluate whether our findings relative to diabetic ulcers could be extended to other complications of diabetes.

Condition or Disease Intervention/Treatment Phase
  • Other: Data collection

Study Design

Study Type:
Observational
Actual Enrollment :
3300000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Impact of COVID-19 Infection and Confinement on Diabetic Ulcer Management and Amputation Risk
Actual Study Start Date :
Oct 16, 2020
Actual Primary Completion Date :
Apr 14, 2021
Actual Study Completion Date :
Apr 14, 2021

Outcome Measures

Primary Outcome Measures

  1. Frequency of lower limb amputations [3 months after the end of the spring 2020 lockdown]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:

Diabetic subjects with hospital stays in France, 2017 to 2020.

Exclusion Criteria:

Absence of diabetes

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourogne Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT04891276
Other Study ID Numbers:
  • PETIT SERI 2020
First Posted:
May 18, 2021
Last Update Posted:
May 18, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2021