(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 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•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
•the plantar side of the foot (plantar hallux and fifth toe) Written informed

•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

发起方

niversitair Medisch Centrum Utrecht