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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Foot Ulcer, Diabetic

Intervention / Treatment
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* Device: Orthèse Diabète
* Device: Conventional Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Orthèse Diabète<br>Using Orthèse Diabète, a new customized removable device with rocker sole for plantar off-loading | Device: Orthèse Diabète<br>* 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.<br>|
| Active Comparator: Control Group<br>Using Conventional devices, removable off-loading systems among the devices available in France | Device: Conventional Device<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients whose principal plantar ulcer will be fully healed | 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. | At 1, 2 and 6 months | 
| Proportion of patients whose all initial plantar ulcers will be fully healed. | 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. | At 1, 2, 3 and 6 months | 
| Percentage decrease of the ulcer area | The area is evaluated by the last measurement undertaken during the trial or prior to a serious event (death, amputation, orthopedic or vascular surgery). | At 1, 2, 3 and 6 months | 
| Time to healing of the principal ulcer |  | From the patient's off-loading device delivery visit to the date of healing validated by the adjudication committee | 
| Appearance of new ulcers on the affected foot and/or contralateral | The following elements will be specified: cause, side, location, severity, treatment used | 6 months | 
| Requirement for amputation | The following elements will be specified: date, side and level. | 6 months | 
| Incidence of infectious complications | 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. | 6 months | 
| Observance of the equipment | 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 | 6 months | 
| Patients satisfaction with the prescribed device | Evaluated with the QUEST ESAT questionnaire | At 3 months |