The Role of Telemedical Monitoring in Diabetic Foot Ulcer Care

NCT ID: NCT02818322

Last Updated: 2016-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-10-31

Brief Summary

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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

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Conditions

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Diabetic Foot - Telemedical Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

telemedical monitoring ( T)

Intervention Type DEVICE

classic monitoring

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

classic monitoring

Intervention Type DEVICE

Interventions

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telemedical monitoring ( T)

Intervention Type DEVICE

classic monitoring

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu de Reims

Reims, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Maud FRANCOIS

Role: CONTACT

Facility Contacts

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Maud FRANCOIS

Role: primary

Other Identifiers

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PA15083

Identifier Type: -

Identifier Source: org_study_id

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