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

Phase 2

Completed

• Conditions: Diabetes; Diabetic Foot Ulcer
• Interventions: Other: telemedicine; Other: conventional

• Registration Number: NCT01814267
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-15
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-19
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-24
• Last Update Posted: 2018-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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))

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine	telemedicine	care and follow-up through telemedicine.
Conventional care	conventional	care and follow-up through iterative diabetes physician consultations (conventional care and follow-up)

Primary Outcome Measures

Name	Time	Method
Assess the incremental cost-effectiveness ratio from the french health system perspective	6 months	It is elaborated from: 1. Main cost criteria: transport, outpatient costs (home nursing care, physicians consultations...), loss of productivity (absence from work); 2. Main clinical effectiveness criterion: wound healing time.

Secondary Outcome Measures

Name	Time	Method
Assess acceptability of telemedicine care (compliance and satisfaction) for patients and nurses.	6 months	Acceptability questionnaire for nurse including use or misuse of telemedicine. Acceptability questionnaire for patient.
Assess the Impact of telemedicine care from the hospital perspective	6 months	The incremental cost-effectiveness ratio is calculated from the hospital perspective: 1. Main cost criteria will be collected according to the micro-costing method: costs of innovative medical device (implementation and maintenance of telemedicine platform), telemedicine physician consultations, standard consumables, cost of care rooms and cost of medical and paramedical staff and, standard consumables for wound treatment.; Costs will not include structural costs; 2. Main clinical effectiveness criterion: wound healing time

Trial Locations

Locations (1)

University Hospital of Grenoble; 🇫🇷 Grenoble, France