Overview

This trial is active, not recruiting.

Conditions diabetes, diabetic foot ulcer
Treatments telemedicine, conventional
Phase phase 2/phase 3
Sponsor University Hospital, Grenoble
Start date March 2013
End date June 2015
Trial size 64 participants
Trial identifier NCT01814267, DCIC 12 07

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
care and follow-up through telemedicine.
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
(Active Comparator)
care and follow-up through iterative diabetes physician consultations (conventional care and follow-up)
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

Primary Outcomes

Measure
Assess the incremental cost-effectiveness ratio from the french health system perspective
time frame: 6 months

Secondary Outcomes

Measure
Assess the Impact of telemedicine care from the hospital perspective
time frame: 6 months
Assess acceptability of telemedicine care (compliance and satisfaction) for patients and nurses.
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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))

Additional Information

Principal investigator Pierre-Yves BENHAMOU, MD PHD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University Hospital, Grenoble.