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

P

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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