DiabetesPhase 2/3AIRPEDIANCT01814267
Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management
A Phase 2/3 study testing telemedicine and conventional in people with Diabetes and Diabetic Foot Ulcer, run by University Hospital, Grenoble at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetic Foot Ulcer
- What is being tested?
- telemedicine and conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Jun 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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))
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetes, Diabetic Foot Ulcer
- Being tested
- telemedicine, conventional
- Keywords
- innovative care, telemedicine, cost effectiveness, diabetes
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | care and follow-up through telemedicine. Receives: Other: telemedicine |
| Conventional care | Active comparator | care and follow-up through iterative diabetes physician consultations (conventional care and follow-up) Receives: Other: conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the incremental cost-effectiveness ratio from the french health system perspective
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.
Measured: 6 months
Secondary outcomes (2)
Assess the Impact of telemedicine care from the hospital perspective
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
Measured: 6 months
Assess acceptability of telemedicine care (compliance and satisfaction) for patients and nurses.
Acceptability questionnaire for nurse including use or misuse of telemedicine. Acceptability questionnaire for patient.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AdministrateurCIC, University Hospital, Grenoble
- Investigators
- Pierre-Yves BENHAMOU, MD PHD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814267
- Sponsor's protocol ID
- DCIC 12 07
- Acronym
- AIRPEDIA
- Status last verified
- May 2018
- First submitted
- 15 Mar 2013
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22067285Foltynski 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.
PubMed 21568750Bowling 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.
PubMed 21134035Larsen 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.
PubMed 17059653Wilbright 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.
PubMed 15192491Muller 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.
PubMed 26696670
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management
- ClinicalTrials.gov ID
- NCT01814267
- Acronym / sponsor ID
- AIRPEDIA / DCIC 12 07
- Conditions
- Diabetes, Diabetic Foot Ulcer
- Keywords
- innovative care, telemedicine, cost effectiveness, diabetes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Other: telemedicinecare and follow-up through telemedicine. |
| Conventional care | Active comparator | Other: conventionalcare and follow-up through iterative diabetes physician consultations (conventional care and follow-up) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with type 1 or 2 diabetes, at least 18 years old
- Patient with a diabetic foot wound :
- 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
Key exclusion criteria (5 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telemedicineIntervention 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 | Other | Telemedicine |
| conventionalconventional 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 | Other | Conventional care |
Primary outcome
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.
2 secondary outcomes
Assess the Impact of telemedicine care from the hospital perspective
Time frame: 6 months
Assess acceptability of telemedicine care (compliance and satisfaction) for patients and nurses.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Background: PubMed 22067285Hazenberg 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.
- Background: PubMed 21568750Foltynski 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.
- Background: PubMed 21134035Bowling 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.
- Background: PubMed 17059653Larsen 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.
- Background: PubMed 15192491Wilbright 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.
- Results publication: PubMed 26696670Muller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Yves BENHAMOU, MD PHD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing telemedicine and conventional in people with Diabetes and Diabetic Foot Ulcer, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the incremental cost-effectiveness ratio from the french health system perspective (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01814267, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.