- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02818322
The Role of Telemedical Monitoring in Diabetic Foot Ulcer Care (A15-06)
June 27, 2016 updated by: CHU de Reims
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maud FRANCOIS
- Email: mfrancois@chu-reims.fr
Study Locations
-
-
-
Reims, France, 51092
- Recruiting
- CHU de Reims
-
Contact:
- Maud FRANCOIS
- Email: mfrancois@chu-reims.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
|
Active Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time of ulcer healing
Time Frame: 6 month after inclusion
|
6 month after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Anticipated)
October 1, 2018
Study Completion (Anticipated)
October 1, 2018
Study Registration Dates
First Submitted
June 23, 2016
First Submitted That Met QC Criteria
June 27, 2016
First Posted (Estimate)
June 29, 2016
Study Record Updates
Last Update Posted (Estimate)
June 29, 2016
Last Update Submitted That Met QC Criteria
June 27, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA15083
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot - Telemedical Monitoring
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Seoul National University HospitalCompletedDiabetic Blood Glucose MonitoringKorea, Republic of
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University of PadovaUnknownDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Deformities FootItaly
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University of MinnesotaRecruitingDiabetes Mellitus | Foot Ulcer | Ulcer | Diabetic Foot Ulcer | Foot Ulcer, Diabetic | Ulcer Foot | Ulcer, Leg | Ankle UlcerUnited States
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