Clinical trial NCT01956162: Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients
Official title: Evaluation of a New Customized Removable Device With Rocker Sole for Plantar Off-Loading "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Ulcer, Diabetic
Lead sponsor: Proteor Group
Sponsor class: INDUSTRY
Collaborators: name: Société Francophone du Diabète
First posted: 2013-10-08
Enrollment: 118
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: Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication committee (PROBE methodology), comparing "Orthèse Diabète" with "conventional" removable devices in terms of healing of ulcers.

- 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.

Detailed description: 1. Secondary objectives

   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.

Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetic patients diagnosed according to the ADA experts consensus \[ADA 1997\]
* 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:

* Severe skin or osteoarticular infection requiring a parenteral antibiotic therapy or surgery
* 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

Primary outcomes:
measure: 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.
timeFrame: At 3 months
Secondary outcomes:
measure: Proportion of patients whose principal plantar ulcer will be fully healed
timeFrame: At 1, 2 and 6 months
measure: Proportion of patients whose all initial plantar ulcers will be fully healed.
timeFrame: At 1, 2, 3 and 6 months
measure: Percentage decrease of the ulcer area
timeFrame: At 1, 2, 3 and 6 months
measure: Time to healing of the principal ulcer
timeFrame: From the patient's off-loading device delivery visit to the date of healing validated by the adjudication committee
measure: Appearance of new ulcers on the affected foot and/or contralateral
timeFrame: 6 months
measure: Requirement for amputation
timeFrame: 6 months
measure: Incidence of infectious complications
timeFrame: 6 months
measure: Observance of the equipment
timeFrame: 6 months
measure: Patients satisfaction with the prescribed device
timeFrame: At 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat Hospital
Study officials:
affiliation: Bichat Hospital
name: Kamel Mohammedi, Diabetology
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.