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Completed

NCT Number: NCT01814267

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

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.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcer Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital of Grenoble

Grenoble, 38049, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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))

Treatment and study plan

Telemedicine

Other

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

Conventional

Other

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

  1. Assess the incremental cost-effectiveness ratio from the french health system perspective

    Time frame: 6 months

    It is elaborated from:

    • Main cost criteria: transport, outpatient costs (home nursing care, physicians consultations...), loss of productivity (absence from work)
    • Main clinical effectiveness criterion: wound healing time.

Secondary outcomes

  1. Assess the Impact of telemedicine care from the hospital perspective

    Time frame: 6 months

    The incremental cost-effectiveness ratio is calculated from the hospital perspective:

    • 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

    • Main clinical effectiveness criterion: wound healing time

  2. Assess acceptability of telemedicine care (compliance and satisfaction) for patients and nurses.

    Time frame: 6 months

    Acceptability questionnaire for nurse including use or misuse of telemedicine. Acceptability questionnaire for patient.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: AIRPEDIA

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2013
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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