Clinical trial NCT03133819: The Early Intervention and Prevention of Diabetes Foot
Official title: The Early Intervention and Prevention of Diabetes Foot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes; Neuropathy, Polyneuropathy (Manifestation)
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycohemoglobin (HbA1c)
timeFrame: month 0, 6, 12
measure: Lipid profile
timeFrame: month 0,6,12
measure: Diabetes nephropathy ( macro-albuminuria (UACR ≧300 mg/g) ，micro-albuminuria (UACR: 30 - 300 mg/g))
timeFrame: month 0,6,12
measure: Peripheral arterial occlusive disease
timeFrame: month 0,6,12
Secondary outcomes:
measure: Diabetes foot
timeFrame: month 0, 6, 12
measure: major lower leg events ( lower leg amputation or revascularization)
timeFrame: month 0,6,12
measure: Major cardiac events ( myocardial infarction, strokes and cardiac related death)
timeFrame: month 0,6,12
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital, Keelung
name: Kuei-Mei Chou, MD
role: PRINCIPAL_INVESTIGATOR
References: