diabetic foot Neuropathy polyneuropathy
Conditions
Interventions
In the intervention group, a surgical release of at least the tibial and common
peroneal nerves, additional decompressions of the superficial and deep peroneal
nerves can be carried out when compres
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Having diabetes mellitus (type 1 or 2) Patients (> 17 and 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complaints (Norfolk QoL-DN). | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (EQ-5D5L, SF-36), plantar sensation, incidence of ulcerations/amputations and resource use during follow-up. The incremental cost-utility ratio will be estimated on the basis of the collected empirical data. | — |
Countries
Netherlands
Outcome results
None listed