The Early Intervention and Prevention of Diabetes Foot

Chang Gung Medical Foundation

Status: Unknown

Conditions: Diabetes; Neuropathy, Polyneuropathy (Manifestation)

Treatments: Device: Q-Sense_QST (TSA II)

Study type: Interventional

Funder types: Other

Identifiers

NCT03133819

CMRPG2F0171

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Group 1: 100 diabetes patients without neuropathy, Q-Sense normal.
• Group 2: 100 diabetes patients with neuropathy, Q-Sense abnormal but no evidence of PAOD.
• Group 3: 100 diabetes patients with neuropathy, Q-Sense abnormal , PAOD (＋), without foot ulceration.
• Group 4: 100 diabetes patients with neuropathy, PAOD (＋), and foot ulceration.

Exclusion criteria

• Poorly controlled hypertension (SBP≥150 under regular medical treatment)
• Thyroid disease
• Pregnancy
• Have been diagnosed malignancy
• Liver cirrhosis

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Q-Sense_QST (TSA II)

Other group

Description:

QST measurement will perform on the thenar eminence of the dominant hand and the lateral distal aspect of the foot dorsum of the same side. Using the method of limits, a threshold will determine as the average of four successive stimuli for cold and warmth sensation and two for heat pain.

Treatment:

Device: Q-Sense_QST (TSA II)