(Cost)-effectiveness of lower extremity nerve decompression surgery in diabetic subjects: the DeCompression (DECO) trial

Recruiting

Conditions: diabetic foot
Neuropathy
10034606
10009720
polyneuropathy

Registration Number: NL-OMON54529

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 344

Inclusion Criteria

Having diabetes mellitus (type 1 or 2) Patients (> 17 and < 76 years old)
Symptoms of neuropathy (assessed with the MNSI, scoring > 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 <10 g monofilament) at
the plantar side of the foot (plantar hallux and fifth toe) Written informed
consent

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Complaints (Norfolk QoL-DN).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Quality of life (EQ-5D5L, SF-36), plantar sensation, incidence of<br /><br>ulcerations/amputations and resource use during follow-up. The incremental<br /><br>cost-utility ratio will be estimated on the basis of the collected empirical<br /><br>data.</p><br>