Clinical trial NCT01814267: Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes
Diabetic Foot Ulcer
Keywords: innovative care
telemedicine
cost effectiveness
diabetes
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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))

Primary outcomes:
measure: Assess the incremental cost-effectiveness ratio from the french health system perspective
timeFrame: 6 months
Secondary outcomes:
measure: Assess the Impact of telemedicine care from the hospital perspective
timeFrame: 6 months
measure: Assess acceptability of telemedicine care (compliance and satisfaction) for patients and nurses.
timeFrame: 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre-Yves BENHAMOU, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hazenberg CE, Bus SA, Kottink AI, Bouwmans CA, Schonbach-Spraul AM, van Baal SG. Telemedical home-monitoring of diabetic foot disease using photographic foot imaging--a feasibility study. J Telemed Telecare. 2012 Jan;18(1):32-6. doi: 10.1258/jtt.2011.110504. Epub 2011 Nov 8.
citation: Foltynski P, Ladyzynski P, Migalska-Musial K, Sabalinska S, Ciechanowska A, Wojcicki J. A new imaging and data transmitting device for telemonitoring of diabetic foot syndrome patients. Diabetes Technol Ther. 2011 Aug;13(8):861-7. doi: 10.1089/dia.2011.0004. Epub 2011 May 13.
citation: Bowling FL, King L, Paterson JA, Hu J, Lipsky BA, Matthews DR, Boulton AJ. Remote assessment of diabetic foot ulcers using a novel wound imaging system. Wound Repair Regen. 2011 Jan-Feb;19(1):25-30. doi: 10.1111/j.1524-475X.2010.00645.x. Epub 2010 Dec 6.
citation: Larsen SB, Clemensen J, Ejskjaer N. A feasibility study of UMTS mobile phones for supporting nurses doing home visits to patients with diabetic foot ulcers. J Telemed Telecare. 2006;12(7):358-62. doi: 10.1258/135763306778682323.
citation: Wilbright WA, Birke JA, Patout CA, Varnado M, Horswell R. The use of telemedicine in the management of diabetes-related foot ulceration: a pilot study. Adv Skin Wound Care. 2004 Jun;17(5 Pt 1):232-8. doi: 10.1097/00129334-200406000-00012.
citation: Muller M, David-Tchouda S, Margier J, Oreglia M, Benhamou PY. Comment on Rasmussen et al. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care 2015;38:1723-1729. Diabetes Care. 2016 Jan;39(1):e9-10. doi: 10.2337/dc15-1659. No abstract available.