The evaluation for efficacy and safety of needle-free subcutaneous injector and conventional intramuscular injection of mecobalamin for diabetic neuropathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
needle-free subcutaneous injector for Mecbl
intramuscular injection of Mecbl
concentration of plasma vitamin B12
The plasma vitamin B12, biomarker for effective active metabolite for neural repair.
Time frame: baseline, half an hour, first hour, second hour, 8 weeks
corneal confocal microscopy parameter: inferior whorl length
The corneal nerve fiber length in inferior whorl area.
Time frame: baseline, 8 weeks
corneal confocal microscopy parameter: corneal nerve fiber length
The corneal nerve fiber length per frame.
Time frame: baseline, 8 weeks
neurological function scales score: the modified Toronto clinical neuropathy score (mTCNS)
mTCNS is a valid and reliable scale for staging of mild to moderate diabetic sensorimotor polyneuropathy. Value of 3 or more is recommended for the diagnosis of peripheral neuropathy.
Time frame: baseline, 8 weeks
neurological function scales score: Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN)
A patient-reported outcomes measure reflecting small fiber, physical functioning/large fiber neuropathy, autonomic nerve function, symptoms, and activities of daily living. Ranges from -4 to 136, higher score indicates worse QOL.
Time frame: baseline, 8 weeks
neurological function scales score: Neuropathy Impairment Score (NIS)
Clinician assessments about cranial nerves and limbs for muscle weakness, sensation loss, and decreased reflexes. ranges from 0 to 244. Higher NIS reflect greater neuropathic impairment.
Time frame: baseline, 8 weeks
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neurological function scales score: Neuropathy Impairment Score of the lower limbs plus seven tests (NIS(LL)+7 tests)
Neuropathy impairment score of the lower limbs plus seven tests includes muscle weakness, sensation loss, and decreased reflexes. Ranges from 0 to 88. More NIS-LL scores indicate greater neuropathic impairment.
Time frame: baseline, 8 weeks
neurological function scales score: Polyneuropathy disability (PND) score
Polyneuropathy disability grades of walking. 0-IV grades were measured. More score is more severe impairment.
Time frame: baseline, 8 weeks
neurological function scales score: DNS score
Score items are unsteadiness of gait, burning or aching sensation, pricking sensation and numbness. A score of one or more denotes the presence of neuropathy.
Time frame: baseline, 8 weeks
neurological function scales score: NDS score
Evaluation of pinprick sensation, vibration sensation and temperature sensation. A total of 10 points was adopted. A score of 6 - 8 denotes the presence of moderate DPN, and a score of 9 - 10 denotes severe DPN.
Time frame: baseline, 8 weeks
neuroelectrophysiological parameter: NCV
Nerve conduction latency
Time frame: baseline, 8 weeks
neuroelectrophysiological parameter: NCV
Nerve conduction velocity
Time frame: baseline, 8 weeks
neuroelectrophysiological parameter: NCV
Nerve conduction wave amplitude
Time frame: baseline, 8 weeks
neuroelectrophysiological parameter: SSR
Velocity of sympathetic skin response
Time frame: baseline, 8 weeks
neuroelectrophysiological parameter: SSR
Amplitude of sympathetic skin response
Time frame: baseline, 8 weeks