Clinical Trials Directory

Trials / Completed

CompletedNCT04891276

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

Status
Completed
Phase
Study type
Observational
Enrollment
3,300,000 (actual)
Sponsor
Centre Hospitalier Universitaire Dijon · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERData collectionData collection on the national PMSI database

Timeline

Start date
2020-10-16
Primary completion
2021-04-14
Completion
2021-04-14
First posted
2021-05-18
Last updated
2026-01-30

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04891276. Inclusion in this directory is not an endorsement.