Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients (ORTHODIAB)

Proteor Group

Status: Completed

Conditions: Foot Ulcer, Diabetic

Treatments: Device: Orthèse Diabète; Device: "Conventional" Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01956162

PROT-ORTHO-0913

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Group "Orthèse Diabète"

Experimental group

Description:

Using "Orthèse Diabète", a new customized removable device with rocker sole for plantar off-loading

Treatment:

Device: Orthèse Diabète

Control Group

Active Comparator group

Description:

Using "Conventional devices", removable off-loading systems among the devices available in France

Treatment:

Device: "Conventional" Device