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临床试验/NL-OMON27360
NL-OMON27360尚未招募不适用

Value of surgical decompression of the nerves of the lower extremities in patients with diabetic polyneuropathy: Lower Extremity Nerve entrapment Study (LENS).

niversity Medical Center Utrecht, Utrecht, The Netherlands0 个研究点目标入组 42 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
42

研究概览

简要总结

/A

研究设计

研究类型
Interventional

入排标准

入选标准

  • Patients with painful diabetic neuropathy, assessed
  • with the Diabetic Neuropathy Symptom score (DNS) and Diabetic Neuropathy Examination (DNE), aged between 18 and 90 will be included. All patients need to have a score of more than 2 on the Visual Analogue Scale (VAS), a positive Tinel sign of the posterior tibial and deep peroneal nerves
  • at the malleoli and dorsum of the foot and a positive Tinel sign of the common peroneal nerve at the proximal fibula. The Ankle-Brachial Index (ABI) should be between 0,8 and 1,15 with palpable peripheral pulsations in the posterior tibial artery and dorsal pedal artery, the Toe-Brachial index (TBI) ≥ 0.7.

排除标准

  • The Body Mass Index should not exceed 35 and the general condition has to be acceptable. The medical history should not include ankle fractures and patients with amputations proximal to the Lisfranc joint are excluded. Patients with ulcers on the foot are excluded. The patient has to be able to understand written en spoken instructions.

研究者

发起方
niversity Medical Center Utrecht, Utrecht, The Netherlands

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