Diabetic Foot - Telemedical Monitoring Clinical Trial
— A15-06Official title:
The Role of Telemedical Monitoring in Diabetic Foot Ulcer Care
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | October 2018 |
| Est. primary completion date | October 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Chu de Reims | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Reims |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | time of ulcer healing | 6 month after inclusion | No |