NL-OMON27360
Not yet recruiting
Not Applicable
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 sites42 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Painful polyneuropathy diabetes mellitus surgery.
- Sponsor
- niversity Medical Center Utrecht, Utrecht, The Netherlands
- Enrollment
- 42
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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