The Role of Telemedical Monitoring in Diabetic Foot Ulcer Care

Not Applicable

• Conditions: Diabetic Foot - Telemedical Monitoring
• Interventions: Device: telemedical monitoring ( T); Device: classic monitoring

• Registration Number: NCT02818322
• Lead Sponsor: CHU de Reims

Brief Summary

The role of telemedical monitoring in diabetic foot care is still uncertain. The aim is to compare telemedical + standard and standard alone outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. The primary outcome of the overall study is the time of ulcer healing. The number of amputation, hospital admissions and surgical procedure will be also reported. Investigators hope to include 150 patients in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-06
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-27
• Last Update Submitted: 2016-06-27
• Study First Posted: 2016-06-29
• Last Update Posted: 2016-06-29
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• The patients treated in the diabetology department of CHU de Reims during the inclusion phase to a diabetic foot lesions ( infected or not).
• Patients with care of this lesion of diabetic foot externally.
• Patients who agreed to participate in or accepting ORNICARE network ( network for the transmission of information between health care professionals) (Appendix 3) .
• Patients aged over 18 years .
• Patients who agreed to participate in the study .
• The patients insured by a social security scheme .

Exclusion Criteria

• Patients requiring hospital care of the lesion of diabetic foot (infection requiring surgical intervention , ischemia requiring revascularization , ...).
• Patients are protected by law .
• Minor patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
telemedical monitoring ( T)	classic monitoring	Home care by a nurse trained in the management of diabetic foot lesions with transmission diabetologist doctor a photograph and a full description of the diabetic foot lesion every week
classic monitoring	classic monitoring	Home care by a nurse trained in the management of diabetic foot lesions without transmission diabetologist doctor a photograph and a full description of the diabetic foot lesion
telemedical monitoring ( T)	telemedical monitoring ( T)	Home care by a nurse trained in the management of diabetic foot lesions with transmission diabetologist doctor a photograph and a full description of the diabetic foot lesion every week

Primary Outcome Measures

Name	Time	Method
time of ulcer healing	6 month after inclusion

Trial Locations

Locations (1)

Chu de Reims; 🇫🇷 Reims, France