CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 14 enrolled
Drug / intervention
telemedicine +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01814267
NCT01814267Phase 3Completed

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

University Hospital, Grenoble·interventional·Posted Mar 19, 2013·Updated May 29, 2018

In Brief

A Phase 3 clinical trial evaluating telemedicine and conventional for Diabetes and Diabetic Foot Ulcer. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 19, 2013
Enrollment StartMar 1, 2013
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.3 years ago

Interventions

telemedicineother

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

conventionalother

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