Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients
NCT ID: NCT01956162
Last Updated: 2017-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
118 participants
INTERVENTIONAL
2013-10-31
2016-12-31
Brief Summary
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\- Primary objective: Evaluate the efficiency of "Orthèse Diabète" compared to "conventional" removable devices, in terms of the proportion of diabetic patients whose principal ulcer will heal completely at 3 months.
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Detailed Description
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1. Proportion of patients whose principal ulcer will heal completely at 1, 2 and 6 months
2. Proportion of patients in whom all initial plantar ulcers will heal completely at 1, 2, 3 and 6 months
3. Percentage of area decrease of the plantar ulcers at 1, 2, 3 and 6 months
4. Time to healing of the principal ulcer
5. Appearance of new ulcers
6. Requirement for amputation
7. Incidence of the infectious complications
8. Adherence of wearing
9. Patient's satisfaction with the prescribed device
2. Population
1. 13 centers/116 patients monitored for a period of 6 months maximum
2. Experimental Group: "Orthèse Diabète" a plantar off-loading custom-made removable device
3. Control group: "Conventional" removable off-loading systems among the devices available in France.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group "Orthèse Diabète"
Using "Orthèse Diabète", a new customized removable device with rocker sole for plantar off-loading
Orthèse Diabète
The device ensures the discharge of the wound by the excavation of the orthopedic insole facing the wound and the load distribution in the healthy areas.
Control Group
Using "Conventional devices", removable off-loading systems among the devices available in France
"Conventional" Device
Standard (e.g.: CHUT, BAROUK, Tera-Diab, Sanital, Teraheel, Aircast boots, Walker Stabil D, etc.), or customized (orthopedic insole, Ransart boot, D.T.A.C.P., etc.) removable off-loading systems
Interventions
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Orthèse Diabète
The device ensures the discharge of the wound by the excavation of the orthopedic insole facing the wound and the load distribution in the healthy areas.
"Conventional" Device
Standard (e.g.: CHUT, BAROUK, Tera-Diab, Sanital, Teraheel, Aircast boots, Walker Stabil D, etc.), or customized (orthopedic insole, Ransart boot, D.T.A.C.P., etc.) removable off-loading systems
Eligibility Criteria
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Inclusion Criteria
* Over 18 years of age
* With a sensory neuropathy (abnormal 10 g monofilament test, i.e. not perceived at least 2 times in 1 of the 3 areas explored : pulp of the great toe, 1st and 5th metatarsal heads)
* Without a severe arteriopathy defined by : ABI \< 0,7 and/or TcPO2 \< 30 mm Hg and/or big toe pressure \< 30 mm Hg
* with one or more plantar ulcerations with an area \> 0,25 cm² or an amputation (toes or transmetatarsal) open or sutured
* not requiring a contralateral off-loading device
* Informed about the study and having given their informed and written consent to participate
* registered with a social security scheme or with the CMU (beneficiary or entitled recipient)
* having undergone a medical exam
* not included in another protocol throughout the study
Exclusion Criteria
* Large ulcer of the ipsilateral leg \> 20 cm2 of area
* Contralateral above heel amputation
* Intercurrent disease prohibiting participation in the protocol
* Weight over 130 Kg
* Person under tutorship or under curatorship
* Loss of functional and/or neuropsychological autonomy
* Pregnant or likely to be pregnant woman
18 Years
ALL
No
Sponsors
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Société Francophone du Diabète
OTHER
Proteor Group
INDUSTRY
Responsible Party
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Principal Investigators
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Kamel Mohammedi, Diabetology
Role: PRINCIPAL_INVESTIGATOR
Bichat Hospital
Locations
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Bichat Hospital
Paris, , France
Countries
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References
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Malgrange D. [Physiopathology of the diabetic foot]. Rev Med Interne. 2008 Sep;29 Suppl 2:S231-7. doi: 10.1016/S0248-8663(08)73950-X. French.
Cavanagh PR, Lipsky BA, Bradbury AW, Botek G. Treatment for diabetic foot ulcers. Lancet. 2005 Nov 12;366(9498):1725-35. doi: 10.1016/S0140-6736(05)67699-4.
Ramsey SD, Newton K, Blough D, McCulloch DK, Sandhu N, Reiber GE, Wagner EH. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999 Mar;22(3):382-7. doi: 10.2337/diacare.22.3.382.
Muller IS, de Grauw WJ, van Gerwen WH, Bartelink ML, van Den Hoogen HJ, Rutten GE. Foot ulceration and lower limb amputation in type 2 diabetic patients in dutch primary health care. Diabetes Care. 2002 Mar;25(3):570-4. doi: 10.2337/diacare.25.3.570.
Detournay B, Cros S, Charbonnel B, Grimaldi A, Liard F, Cogneau J, Fagnani F, Eschwege E. Managing type 2 diabetes in France: the ECODIA survey. Diabetes Metab. 2000 Nov;26(5):363-9.
Detournay B, Raccah D, Cadilhac M, Eschwege E. Epidemiology and costs of diabetes treated with insulin in France. Diabetes Metab. 2005 Jun;31(3 Pt 2):3-18.
Malgrange D, Richard JL, Leymarie F; French Working Group On The Diabetic Foot. Screening diabetic patients at risk for foot ulceration. A multi-centre hospital-based study in France. Diabetes Metab. 2003 Jun;29(3):261-8. doi: 10.1016/s1262-3636(07)70035-6.
Apelqvist J, Larsson J, Agardh CD. Long-term prognosis for diabetic patients with foot ulcers. J Intern Med. 1993 Jun;233(6):485-91. doi: 10.1111/j.1365-2796.1993.tb01003.x.
Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. doi: 10.1016/S0140-6736(05)67698-2.
Moxey PW, Hofman D, Hinchliffe RJ, Jones K, Thompson MM, Holt PJ. Epidemiological study of lower limb amputation in England between 2003 and 2008. Br J Surg. 2010 Sep;97(9):1348-53. doi: 10.1002/bjs.7092.
Resnick HE, Carter EA, Sosenko JM, Henly SJ, Fabsitz RR, Ness FK, Welty TK, Lee ET, Howard BV; Strong Heart Study. Incidence of lower-extremity amputation in American Indians: the Strong Heart Study. Diabetes Care. 2004 Aug;27(8):1885-91. doi: 10.2337/diacare.27.8.1885.
Fosse S, Hartemann-Heurtier A, Jacqueminet S, Ha Van G, Grimaldi A, Fagot-Campagna A. Incidence and characteristics of lower limb amputations in people with diabetes. Diabet Med. 2009 Apr;26(4):391-6. doi: 10.1111/j.1464-5491.2009.02698.x.
Potier L, Francois M, Dardari D, Feron M, Belhatem N, Nobecourt-Dupuy E, Dolz M, Bordier L, Ducloux R, Chibani A, Eveno DF, Crea Avila T, Sultan A, Baillet-Blanco L, Rigalleau V, Gand E, Saulnier PJ, Velho G, Roussel R, Pellenc Q, Dupre JC, Malgrange D, Marre M, Mohammedi K; ORTHODIAB study group. Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial. BMJ Open Diabetes Res Care. 2020 May;8(1):e000954. doi: 10.1136/bmjdrc-2019-000954.
Mohammedi K, Potier L, Francois M, Dardari D, Feron M, Nobecourt-Dupuy E, Dolz M, Ducloux R, Chibani A, Eveno DF, Crea Avila T, Sultan A, Baillet-Blanco L, Rigalleau V, Velho G, Tubach F, Roussel R, Dupre JC, Malgrange D, Marre M. The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rational. J Foot Ankle Res. 2016 Aug 22;9(1):34. doi: 10.1186/s13047-016-0163-4. eCollection 2016.
Related Links
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Francophone Diabetes Society Website
Other Identifiers
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PROT-ORTHO-0913
Identifier Type: -
Identifier Source: org_study_id
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