The Role of Telemedical Monitoring in Diabetic Foot Ulcer Care (A15-06)

CHU de Reims

Status: Unknown

Conditions: Diabetic Foot - Telemedical Monitoring

Treatments: Device: classic monitoring; Device: telemedical monitoring ( T)

Study type: Interventional

Funder types: Other

Identifiers

NCT02818322

PA15083

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 2 patient groups

telemedical monitoring ( T)

Experimental group

Description:

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

Treatment:

Device: classic monitoring

Device: telemedical monitoring ( T)

classic monitoring

Active Comparator group

Description:

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

Treatment:

Device: classic monitoring