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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
-
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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.
次要结局
- Proportion of patients whose principal plantar ulcer will be fully healed(At 1, 2 and 6 months)
- Proportion of patients whose all initial plantar ulcers will be fully healed.(At 1, 2, 3 and 6 months)
- Percentage decrease of the ulcer area(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(6 months)
- Requirement for amputation(6 months)
- Incidence of infectious complications(6 months)
- Observance of the equipment(6 months)
- Patients satisfaction with the prescribed device(At 3 months)