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

NCT04891276 | Completed

• 1 other identifier: PETIT SERI 2020
• Study Type: observational
• Target: 3,300,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Subjects With Hospital Stays

Outcome Measures

Primary Outcomes (1)

• Frequency of lower limb amputations

  3 months after the end of the spring 2020 lockdown

Interventions

Data collection OTHER

Data collection on the national PMSI database

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Absence of diabetes

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Related Publications (1)

• Mariet AS, Benzenine E, Bouillet B, Verges B, Quantin C, Petit JM. Impact of the COVID-19 Epidemic on hospitalization for diabetic foot ulcers during lockdown: A French nationwide population-based study. Diabet Med. 2021 Jul;38(7):e14577. doi: 10.1111/dme.14577. Epub 2021 Apr 13.

  PMID: 33797791 RESULT

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

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

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 18, 2021
• Study Start: October 16, 2020
• Primary Completion: April 14, 2021
• Study Completion: April 14, 2021
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

FR (1)