Value of surgical decompression of the nerves of the lower extremities in patients with painful diabetic polyneuropathy: Lower Extremity Nerve entrapment Study (LENS)

Value of surgical decompression of the nerves of the lower extremities in patients with painful diabetic polyneuropathy: Lower Extremity Nerve entrapment Study (LENS) - Lower Extremity Nerve entrapment Study (LENS)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39394

Enrollment

164

Registered

2010-10-28

Start date

2011-02-07

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nerve entrapment caused by diabetes

Interventions

Decompression of the lower limb nerves includes: the posterior tibial nerve and its calcaneal, medial and lateral plantar branches at the ankle, the deep peroneal nerve over the dorsum of the foot,

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Painful Diabetic Neuropathy positive Tinel sign age 18-90;first control group: the same inclusion criteria but without diabetic neuropathy second control group: people without diabetes mellitus and without neuropathy

Exclusion criteria

Exclusion criteria: need for vascular surgical intervention of the extremity ulcers on the foot Sufficiënt treatment of pain with medication( VAS 0-1) neuropathy caused by other factors than diabetes mellitus patients with physical problems leading to instability;control group: anamnestic signs of periheral neuropathy control group ultrasound: anamnastic signs of peripheral neuropathy

Design outcomes

Primary

Measure	Time frame
To study the influence of decompression on pain. Evaluation of pain with the Visual Analogue Scale. The VAS will be used for both legs separately. The VAS is a straight line, the ends of which are the extreme limits of the sensation being assessed. The line is 10 cm in length using a 10-point scale ranging from 1 to 10, with 1 being barely perceptible and 10 being intolerably painful. Primary endpoint will be VAS	—

Measure

Time frame

To study the influence of decompression on pain. Evaluation of pain with the Visual Analogue Scale. The VAS will be used for both legs separately. The VAS is a straight line, the ends of which are the extreme limits of the sensation being assessed. The line is 10 cm in length using a 10-point scale ranging from 1 to 10, with 1 being barely perceptible and 10 being intolerably painful. Primary endpoint will be VAS

—

Secondary

Measure	Time frame
To study the effect of decompression on vibration perceprion threshold and tactile sensation Evaluation of the Vibration Perception Threshold (VPT) with the biothesiometer: The VPT will be determined using a hand-held biothesiometer (Biomedical Instruments, Newbury, OH). VPT will be tested on the tip of the hallux. The biothesiometer is a device with a rubber probe that vibrates at 100 Hz. The unit contains a linear scale that displays the applied voltage, ranging from 0 to 50 V. The voltage of vibration will be increased until the patient can perceive a vibration. The mean of three readings will be used to determine the VPT. A VPT value of >25V in at least one foot has been associated with a high cumulative risk of neuropathic ulceration. Values between 16 and 24V indicate intermediate risk and values	—

Measure

Time frame

To study the effect of decompression on vibration perceprion threshold and tactile sensation Evaluation of the Vibration Perception Threshold (VPT) with the biothesiometer: The VPT will be determined using a hand-held biothesiometer (Biomedical Instruments, Newbury, OH). VPT will be tested on the tip of the hallux. The biothesiometer is a device with a rubber probe that vibrates at 100 Hz. The unit contains a linear scale that displays the applied voltage, ranging from 0 to 50 V. The voltage of vibration will be increased until the patient can perceive a vibration. The mean of three readings will be used to determine the VPT. A VPT value of >25V in at least one foot has been associated with a high cumulative risk of neuropathic ulceration. Values between 16 and 24V indicate intermediate risk and values

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)