Value of surgical decompression of the nerves of the lower extremities in patients with diabetic polyneuropathy: Lower Extremity Nerve entrapment Study (LENS).
- Conditions
- Painful polyneuropathy diabetes mellitus surgery.
- Registration Number
- NL-OMON27360
- Lead Sponsor
- niversity Medical Center Utrecht, Utrecht, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 42
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint will be Visual Analogue Scale (VAS) <<br>2 or a significantly greater change in VAS in the treated limb compared with the contralateral limb after 6 months.
- Secondary Outcome Measures
Name Time Method