ACTRN12620000699965尚未招募未知
Footwear and insole design parameters to prevent occurrence and recurrence of neuropathic plantar forefoot ulcers in patients with diabetes; - A series of N-of-1 trials.
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participants will be adults ( over 18 years of age) with type-1 or type-2 diabetes, peripheral neuropathy and recently healed plantar forefoot ulcer. Participants may have at least one or more forefoot deformities such as claw/hammer toes, cross over toes, hallux valgus, hallux amputation, limited joint mobility, pes planus or, pes cavus and bony prominences at metatarsal heads. Participants will have required referral for orthopedic footwear (either custom-made or prefabricated medical grade footwear with or without modification) and custom-made insoles, and have adequate English communication skills to provide informed consent and comprehend the study procedures.
排除标准
- •Exclusion criteria will be bilateral amputation (proximal to the trans-metatarsal joint), active or inactive Charcot foot, healed heel ulcers, midfoot deformities, use of walking aid for off-loading the foot, or severe illness, such that the participant may not survive for the study period.
研究者
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