NCT01814267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 diabetes

Timeline
Completed

Started Mar 2013

Typical duration for phase_2 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 29, 2018

Status Verified

May 1, 2018

Enrollment Period

2.3 years

First QC Date

March 15, 2013

Last Update Submit

May 24, 2018

Conditions

DiabetesDiabetic Foot Ulcer

Keywords

innovative caretelemedicinecost effectivenessdiabetes

Outcome Measures

Primary Outcomes (1)

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

    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.

    6 months

Secondary Outcomes (2)

  • Assess the Impact of telemedicine care from the hospital perspective

    6 months

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

    6 months

Study Arms (2)

Telemedicine

EXPERIMENTAL

care and follow-up through telemedicine.

Other: telemedicine

Conventional care

ACTIVE COMPARATOR

care and follow-up through iterative diabetes physician consultations (conventional care and follow-up)

Other: conventional

Interventions

telemedicineOTHER

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

Telemedicine
conventionalOTHER

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

Conventional care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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))

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Grenoble

Grenoble, 38049, France

Location

Related Publications (6)

  • 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.

    PMID: 22067285BACKGROUND

  • 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.

    PMID: 21568750BACKGROUND

  • 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.

    PMID: 21134035BACKGROUND

  • 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.

    PMID: 17059653BACKGROUND

  • 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.

    PMID: 15192491BACKGROUND

  • 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.

    PMID: 26696670RESULT

MeSH Terms

Conditions

Diabetes MellitusDiabetic Foot

Interventions

TelemedicineCongresses as Topic

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationOrganizationsHealth Care Economics and Organizations

Study Officials

  • Pierre-Yves BENHAMOU, MD PHD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pr Pierre-Yves BENHAMOU, University Hospital, Grenoble

Study Record Dates

First Submitted

March 15, 2013

First Posted

March 19, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 29, 2018

Record last verified: 2018-05

Locations

FR(1)