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

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Diabetes

Diabetic Foot Ulcer

Treatments

Other: conventional

Other: telemedicine

Study type

Interventional

Funder types

Other

Identifiers

NCT01814267

DCIC 12 07

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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))