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Completed

NCT Number: NCT01956162

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

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.

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Key information

Conditions

Foot Ulcer, Diabetic Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bichat Hospital

Paris, 75877, France

About this study

  • Secondary objectives
  • Proportion of patients whose principal ulcer will heal completely at 1, 2 and 6 months
  • Proportion of patients in whom all initial plantar ulcers will heal completely at 1, 2, 3 and 6 months
  • Percentage of area decrease of the plantar ulcers at 1, 2, 3 and 6 months
  • Time to healing of the principal ulcer
  • Appearance of new ulcers
  • Requirement for amputation
  • Incidence of the infectious complications
  • Adherence of wearing
  • Patient's satisfaction with the prescribed device
  • Population
  • 13 centers/116 patients monitored for a period of 6 months maximum
  • Experimental Group: "Orthèse Diabète" a plantar off-loading custom-made removable device
  • Control group: "Conventional" removable off-loading systems among the devices available in France.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthèse Diabète

Device

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

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Proteor Group

Industry

Collaborators

  • Société Francophone du Diabète

Registry information

Official study 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

Acronym: ORTHODIAB

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2013
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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