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Clinical Trials/NCT02818322
NCT02818322
Unknown
Not Applicable

The Role of Telemedical Monitoring in Diabetic Foot Ulcer Care

CHU de Reims1 site in 1 country150 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Foot - Telemedical Monitoring
Sponsor
CHU de Reims
Enrollment
150
Locations
1
Primary Endpoint
time of ulcer healing
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
October 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

time of ulcer healing

Time Frame: 6 month after inclusion

Study Sites (1)

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