Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-06-30

Brief Summary

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The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers.

Patients will be randomized into 2 groups: 1/conventional care group with iterative visits to diabetes specialist or 2/innovative care (telemedicine group).

the health insurance system perspective is adopted.

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Detailed Description

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Conditions

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Diabetes Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telemedicine

care and follow-up through telemedicine.

Group Type EXPERIMENTAL

telemedicine

Intervention Type OTHER

Intervention group: care and follow-up through telemedicine (e-consultations)

* 1 hospital consultation at inclusion time, week 0
* then every 15 days, after the transmission of medical data and photos via internet by the nurse, telemedicine e-consultations until the wound has healed (week 2,week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 18, week 20, week 22, week 24 : end point study), i.e. 12 e-consultations over a 6-month period.
* 1 hospital consultation to validate that the wound is well-healed

Conventional care

care and follow-up through iterative diabetes physician consultations (conventional care and follow-up)

Group Type ACTIVE_COMPARATOR

conventional

Intervention Type OTHER

conventional group: iterative diabetes physicians consultations at hospital

* 1 consultation at inclusion time, week 0
* 1 consultation 2 weeks after inclusion, week 2
* 1 consultation per month until the wound has healed (week 4, week 8, week 12, week 16, week 20, week 24: end-point study), i.e. 6 consultations over a 6-month period
* 1 consultation to validate that the wound is well-healed

Interventions

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telemedicine

Intervention group: care and follow-up through telemedicine (e-consultations)

* 1 hospital consultation at inclusion time, week 0
* then every 15 days, after the transmission of medical data and photos via internet by the nurse, telemedicine e-consultations until the wound has healed (week 2,week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 18, week 20, week 22, week 24 : end point study), i.e. 12 e-consultations over a 6-month period.
* 1 hospital consultation to validate that the wound is well-healed

Intervention Type OTHER

conventional

conventional group: iterative diabetes physicians consultations at hospital

* 1 consultation at inclusion time, week 0
* 1 consultation 2 weeks after inclusion, week 2
* 1 consultation per month until the wound has healed (week 4, week 8, week 12, week 16, week 20, week 24: end-point study), i.e. 6 consultations over a 6-month period
* 1 consultation to validate that the wound is well-healed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with type 1 or 2 diabetes, at least 18 years old
* Patient with a diabetic foot wound :

* Acute or chronic (evolving for at least 30 days)
* size ≤ to 3 cm²
* Level I, II or III, stage A or B, excluding stages C and D from the University of Texas Wound Classification Systems
* Person affiliated to French Health insurance or equivalent
* Person having signed freely the consent form after receiving sufficient information
* Treatment compliance and 6 months follow-up feasible

Exclusion Criteria

* Patient with a ischemic wound: Ankle-Brachial Index (ABI) \<0.9 or Transcutaneous oxygen pressure (TcpO2) \< 30 mmHg (stage C and D from the University of Texas Wound Classification Systems)
* Patient with emergency hospitalization indication whatever the reasons.
* Person deprived of liberty by a legal or administrative decision, patients in emergency and people hospitalised without consent and who are not protected by law.
* Pregnant or breastfeeding women
* Patient currently participating in another telemedicine research protocol (such as : Study on the impact of Telemedicine on the management of patients with type 1 diabetes (TELEDIAB-3))

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No