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Clinical Trials/NL-OMON27360
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

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
niversity Medical Center Utrecht, Utrecht, The Netherlands

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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