Painful polyneuropathy diabetes mellitus surgery.
Conditions
Interventions
The intervention consists of surgical decompression of
the nerves of one lower limb in 42 patients. Surgery will be performed within 6 weeks after randomisation.
The contralateral limb will serve as
Sponsors
University Medical Center Utrecht, Utrecht, The Netherlands
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint will be Visual Analogue Scale (VAS) < 2 or a significantly greater change in VAS in the treated limb compared with the contralateral limb after 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study the influence of decompression on vibration perception threshold and tactile sensation; 2. To study the effect of decompression on prevention of foot ulcers and amputations; 3. To describe functional status of patients with diabetic polyneuropathy; 4. To study the effect of decompression on functional status of patients with painful neuropathy; 5. To study if the posterior tibial nerve can anatomically recover after decompression of the tarsal tunnel. To study the reduction of edema in the tarsal tunnel and the thickness of the ligament covering the tarsal tunnel; 6. To study the effect of decompression on postural stability; 7. To study the effect of decompression on foot temperature as an autonomic nerve function; 8. To study the cost-effectiveness of surgical decompression of pedal nerves compared with medical therapy; 9. To study the effect of decompression on nerve conduction; 10. Health status measured with EQ-5D. | — |
Contacts
Public ContactJ.F.M. Macare van Maurik
Po Box 85500
Outcome results
None listed