Diabetes; Neuropathy, Polyneuropathy (Manifestation) Clinical Trial
Official title:
The Early Intervention and Prevention of Diabetes Foot
Peripheral neuropathy is just assessed by determination of Vibration sensation, pressure
sensation, superficial pain or temperature. The most commonly used technique for diagnosis
of peripheral neuropathy is nervous conduction (NC) and electromyography (EMG). But EMG/NC
is bothersome and techniques using electric currents to measure NC and needles to study
muscle innervations are uncomfortable.
Quantitative NeuroSensory Testing (QST) is essential in the evaluation of small-caliber
A-delta and C-fibers, the primary transmitters of thermal and pain sensation. QST can
demonstrate neurosensory abnormalities when it is non-invasive test, selective to small
fibers despite negative EMG/NCV finding.
The investigators predict QST can be used for the early diagnosis and follow-up of
small-fiber neuropathy in diabetes patients. The investigators also predict the early
evaluation of diabetes neuropathy with QST can reduce the diabetes patient progress to
advance stage of DM foot or limb amputation.
Patients will be divide into 4 groups (groups 1 to 4 will be divided by Q-Sense QST (TSA II)
. The patient groups will be defined as the followings:
1. Group 1: 100 diabetes patients without neuropathy, Q-Sense normal.
2. Group 2: 100 diabetes patients with neuropathy, Q-Sense abnormal but no evidence of
PAOD.
3. Group 3: 100 diabetes patients with neuropathy, Q-Sense abnormal , PAOD (＋), but no
foot ulceration
4. Group 4: 100 diabetes patients with neuropathy, PAOD(＋) , and foot ulceration QST will
perform using the Medoc device (TSA2001/VSA3001) following previous published
procedures.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05787990 -
Time-In-Range Based Risk Stratification of Type 2 Diabetes Microvascular Complications
|
||
| Enrolling by invitation |
NCT05639478 -
FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care
|
N/A |