NCT00803608已完成2 期
Prospective, Randomized, Multiple Site Clinical Trial Comparing the Effectiveness of Novel Pressure Based Insoles to Current Care For Ulcer Prevention
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 22
- 主要终点
- The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer
研究概览
简要总结
To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in recurrence of plantar MTH ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes Mellitus type 1 or type 2 who have had at least one recently healed plantar MTH foot ulcer (>1 week but <12 weeks since heeling) and have Loss of Protective Sensation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Men and women, 18 years of age or older at the time of consent;
- •Clinical diagnosis of Diabetes Mellitus ;
- •At least one recently healed plantar MTH-related foot ulcer (>1 week but 4 months since heeling), based on medical records or if these cannot be obtained to the subject's best recollection OR current or recurring hemorrhage into callus under at least one MTH in a patient with a prior MTH related plantar ulcer that has been documented in the medical record;
- •Barefoot plantar pressure in the area of the previous MTH-related ulcer or at the area of current hemorrhagic callus >450 kPa;
- •Loss of Protective Sensation (refer to Section 7.2.6);
- •Community ambulator defined as having the ability or potential for ambulation outside in the community including the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces, or better by subject report;
- •Ability to give consent;
- •In the opinion of the site PI the subject is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures for the duration of the study.
排除标准
- •Presence of a current ulcer (see Section 7.1.1) below the malleoli, in the opinion of the site PI;
- •Partial foot amputation greater than of two metatarsal heads or rays per foot; toe amputations with the metatarsal heads left in place are permissible; complete foot amputation on one side (i.e. ambulation with a prosthesis) is permissible;
- •Charcot process that is active in the opinion of the site PI (requires immobilization beyond use of footwear that would be available through the study);
- •A prior ulcer on the plantar aspect of the heel within the last year, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
- •A prior ulcer on the weightbearing aspect of any toe within the last year, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
- •A prior ulcer on the plantar aspect of the foot associated with a mid-foot prominence at any time in the past, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
- •A prior ulcer on the plantar aspect of the foot associated with a mid-foot prominence at any time in the past, if the associated plantar pressure is >450kPa
- •Barefoot plantar pressure in the mid-foot that exceeds forefoot peak plantar pressure;
- •Need for an ankle-foot orthoses in the opinion of the site PI or another provider;
- •Need for more complex intervention, i.e. the site PI's decision is that the study footwear would not be adequate for the subject's needs, e.g. a rigid outsole or custom molded shoes are deemed necessary.
研究组 & 干预措施
02
Active Comparator
Current standard of care insole
干预措施: Current standard of care insole (Device)
01
Experimental
TrueContour® insole
干预措施: TrueContour® Insole (Device)
结局指标
主要结局
The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer
时间窗: every 3 months
次要结局
未报告次要终点
研究者
研究点 (22)
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