NL-OMON54529
招募中
不适用
(Cost)-effectiveness of lower extremity nerve decompression surgery in diabetic subjects: the DeCompression (DECO) trial - DECO trial
niversitair Medisch Centrum Utrecht0 个研究点目标入组 344 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- diabetic foot
- 发起方
- niversitair Medisch Centrum Utrecht
- 入组人数
- 344
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Having diabetes mellitus (type 1 or 2\) Patients (\> 17 and \< 76 years old)
- •Symptoms of neuropathy (assessed with the MNSI, scoring \> 3\) A bilateral Tinel
- •sign at the tarsal tunnel (n. tibialis posterior) Sufficient circulation to
- •heal lower\-extremity incision (by palpating the peripheral arteries of the
- •foot: a palpable dorsal pedis artery or posterior tibial artery is needed). In
- •case of non\-palpable arteries a pedal Doppler arterial waveform is evaluated. A
- •toe brachial index is performed when the Doppler signal is not triphasic·
- •Minimal or controlled pedal oedema (assessed with inspection and physical
- •examination) Being fit for surgery Compliant with instructions for their own
- •care\* Intact protective sensation (cutaneous threshold \<10 g monofilament) at
排除标准
- •DFU(s) or amputation(s) in history, active radicular syndrome or neurological
- •disease interfering with sensation of the feet, as assessed in the interview
- •and screening questionnaire (e.g. HIV and chemotherapy induced neuropathy)
- •Previous surgery at lower extremity nerve compression sites Active Charcot foot
- •Not able to understand written and oral instructions (i.e. insufficient command
- •of Dutch language) Being incompetent (incapacitated) Current enrollment in a
- •clinical trial which involves surgery of the lower extremity or medical drug
- •trials investigating the effects on neuropathy symptoms. HbA1c level \> 11% at
- •baseline Pregnant women
结局指标
主要结局
未指定
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