NCT03133819

The Early Intervention and Prevention of Diabetes Foot

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes; Neuropathy, Polyneuropathy (Manifestation)

Interventions

Type	Name	Description
DEVICE	Q-Sense_QST (TSA II)	QST will perform using the Medoc device (TSA2001/VSA3001) following previous published procedures. The measurement will perform on the thenar eminence of the dominant hand and the lateral distal aspect of the foot dorsum of the same side.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2017-04-28
• Last updated: 2017-05-08