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

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ClinicalTrials.gov Identifier: NCT01956162
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : June 1, 2017
Sponsor:
Collaborator:
Société Francophone du Diabète
Information provided by (Responsible Party):
Proteor Group

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.


Condition or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Device: Orthèse Diabète Device: "Conventional" Device Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Group "Orthèse Diabète"
Using "Orthèse Diabète", a new customized removable device with rocker sole for plantar off-loading
Device: 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.

Active Comparator: Control Group
Using "Conventional devices", removable off-loading systems among the devices available in France
Device: "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




Primary Outcome Measures :
  1. 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. [ Time Frame: At 3 months ]
    Evaluated by taking photographs, measuring the ulcer area (using Digital Photo Planimetry DPP and the software Tracer.exe). Full healing defined by the adjudication committee based on the analysis of the photographs.


Secondary Outcome Measures :
  1. Proportion of patients whose principal plantar ulcer will be fully healed [ Time Frame: At 1, 2 and 6 months ]
    Evaluated by taking photographs, measuring the ulcer area (using Digital Photo Planimetry DPP and the software Tracer.exe). Full healing defined by the adjudication committee based on the analysis of the photographs.

  2. Proportion of patients whose all initial plantar ulcers will be fully healed. [ Time Frame: At 1, 2, 3 and 6 months ]
    Evaluated by taking photographs, measuring the ulcer area (using Digital Photo Planimetry DPP and the software Tracer.exe). Full healing defined by the adjudication committee based on the analysis of the photographs.

  3. Percentage decrease of the ulcer area [ Time Frame: At 1, 2, 3 and 6 months ]
    The area is evaluated by the last measurement undertaken during the trial or prior to a serious event (death, amputation, orthopedic or vascular surgery).

  4. Time to healing of the principal ulcer [ Time Frame: From the patient's off-loading device delivery visit to the date of healing validated by the adjudication committee ]
  5. Appearance of new ulcers on the affected foot and/or contralateral [ Time Frame: 6 months ]
    The following elements will be specified: cause, side, location, severity, treatment used

  6. Requirement for amputation [ Time Frame: 6 months ]
    The following elements will be specified: date, side and level.

  7. Incidence of infectious complications [ Time Frame: 6 months ]
    This covers cutaneous infections (abscess and lymphangitis, erysipelas, hypodermitis, necrotizing fasciitis, gas gangrene), bone infections (osteitis, arthritis, osteoarthritis) or systemic infections requiring antibiotic therapy (oral or parenteral) or surgery.

  8. Observance of the equipment [ Time Frame: 6 months ]
    Daily wear will be evaluated in the 2 groups through a semi-quantitative questionnaire provided to the patient at every visit. This evaluation will be supplemented with readings of the thermal sensor in the "Orthèse Diabète " group

  9. Patients satisfaction with the prescribed device [ Time Frame: At 3 months ]
    Evaluated with the "QUEST ESAT" questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956162


Locations
France
Bichat Hospital
Paris, France, 75877
Sponsors and Collaborators
Proteor Group
Société Francophone du Diabète
Investigators
Principal Investigator: Kamel Mohammedi, Diabetology Bichat Hospital

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Proteor Group
ClinicalTrials.gov Identifier: NCT01956162     History of Changes
Other Study ID Numbers: PROT-ORTHO-0913
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies