Status:
COMPLETED
Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Diabetes
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 iterati...
Eligibility Criteria
Inclusion
- 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
- 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))
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01814267
Start Date
March 1 2013
End Date
June 1 2015
Last Update
May 29 2018
Active Locations (1)
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1
University Hospital of Grenoble
Grenoble, France, 38049