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Trial record 26 of 43 for:    Diabetic Foot | First posted from 01/01/2013 to 11/22/2013

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01814267
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
AdministrateurCIC, 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.


Condition or disease Intervention/treatment Phase
Diabetes Diabetic Foot Ulcer Other: telemedicine Other: conventional Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : March 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015


Arm Intervention/treatment
Experimental: Telemedicine
care and follow-up through telemedicine.
Other: telemedicine

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

Active Comparator: Conventional care
care and follow-up through iterative diabetes physician consultations (conventional care and follow-up)
Other: conventional

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 Outcome Measures :
  1. Assess the incremental cost-effectiveness ratio from the french health system perspective [ Time Frame: 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 :
  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:

    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

  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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))

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814267


Locations
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France
University Hospital of Grenoble
Grenoble, France, 38049
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Pierre-Yves BENHAMOU, MD PHD University Hospital, Grenoble
Publications of Results:
Other Publications:
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Responsible Party: AdministrateurCIC, Pr Pierre-Yves BENHAMOU, University Hospital, Grenoble, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01814267    
Other Study ID Numbers: DCIC 12 07
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018
Keywords provided by AdministrateurCIC, University Hospital, Grenoble:
innovative care
telemedicine
cost effectiveness
diabetes
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Diabetic Neuropathies
Foot Diseases
Diabetes Mellitus
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications