Diabetes Mellitus Neuropathy Compression neuropathy
Conditions
Interventions
Lower extremity Nerve Decompression surgery
Sponsors
UMC Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: • Having diabetes mellitus (type 1 or 2) • Patients (> 17 and 3) • A bilateral Tinel sign at the tarsal tunnel (posterior tibial nerve) • Sufficient circulation to heal lower-extremity incisions (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 edema (assessed with inspection and physical examination) • Being fit for surgery • Compliant with instructions for their own care • Intact protective sensation (cutaneous threshold <10 g monofilament) at the plantar side of the foot (plantar hallux and fifth toe) • Written informed consent
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 |
|---|---|
| Primary objective: to study the influence of LEND surgery on disease-specific quality of life as measured on the Norfolk-QoL-DN questionnaire, at 48 months follow-up. Primary endpoint: the difference between the total Norfolk-QoL-DN score at baseline compared to the score at 48 months between the intervention and control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Short term: 1) To study the influence of LEND surgery on balance and gait parameters at 24 months. Endpoint: the difference between pedobarographic and pedothermographic imaging results between the intervention and control group. 2) To study to what extent pre-operative electrodiagnostic studies (used to grade the severeness of DSP) account for the variation in surgical outcome (HRQoL: Norfolk-QoL-DN, SF-36, EQ-5D) at 24 months. Endpoint: the influence of electrodiagnostic parameters (CMAP, DML, SNAP ) on the difference in scores of the HRQoL between the intervention and control group. 3) To study to what extent pre-operative nerve damage influences the results of LEND surgery on balance and gait parameters, VAS neuropathy scores, HRQoL and symptoms at 24 months. Endpoint: the influence of RDF Test Battery scores on the difference in balance and gait parameters, VAS neuropathy scores, HRQoL and symptoms (MNSI) between the intervention and control group. Long term: 1) To study if LEND surgery is (cost)effective, compared to current care (HRQoL, resource use, productivity loss), at 48 months. Endpoint: the difference between HRQoL, resource use (based on data from hospital financial systems, general practitioner, national databases) and productivity loss (iMCQ and iPCQ) between the intervention and control group. Cost-effectiveness will be evaluated as the incremental cost-utility ratio (ICUR/ICER) of LEND surgery compared to current best care 2) The influence of LEND surgery on gain in sensory function (measured with the RDF Test Battery) at 48 months. Endpoint: the difference in RDF Test Battery scores between the intervention and control group 3) To study to what extent this surgical procedure results in lower risk of diabetic foot ulceration, amputation and falls at 48 months. Endpoint: the difference in incident diabetic foot ulceration, amputation and falls between the intervention and control group. 4) To study to what extent pre-operative nerve damage | — |
Contacts
Public ContactWillem Rinkel
UMC Utrecht
Outcome results
None listed