Foot Ulcer, Diabetic
Conditions
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.
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.
Interventions
DEVICEOrthèse 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.
DEVICEConventional 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
Sponsors
Société Francophone du Diabète
Proteor Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients whose all initial plantar ulcers will be fully healed. | 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. |
| Percentage decrease of the ulcer area | 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). |
| 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 | 6 months | The following elements will be specified: cause, side, location, severity, treatment used |
| Proportion of patients whose principal plantar ulcer will be fully healed | 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. |
| Incidence of infectious complications | 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. |
| Observance of the equipment | 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 |
| Patients satisfaction with the prescribed device | At 3 months | Evaluated with the QUEST ESAT questionnaire |
| Requirement for amputation | 6 months | The following elements will be specified: date, side and level. |
Countries
France
Outcome results
None listed