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

Grenoble Alpes University Hospital Center (CHU) logo

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))

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

14 participants in 2 patient groups

Telemedicine
Experimental group
Description:
care and follow-up through telemedicine.
Treatment:
Other: telemedicine
Conventional care
Active Comparator group
Description:
care and follow-up through iterative diabetes physician consultations (conventional care and follow-up)
Treatment:
Other: conventional

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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