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.

Study Overview

• Status: Unknown
• Conditions: Diabetes; Neuropathy, Polyneuropathy (Manifestation)
• Intervention / Treatment: Device: Q-Sense_QST (TSA II)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Q-Sense_QST (TSA II); 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycohemoglobin (HbA1c)	To see the correlation between diabetes neuropathy (by Q sense measurement) and glycemic control status ( at baseline, 6 months and 12 months).	month 0, 6, 12
Lipid profile	To see the correlation between diabetes neuropathy (by Q sense measurement) and lipid profile ( at baseline, 6 months and 12 months).	month 0,6,12
Diabetes nephropathy ( macro-albuminuria (UACR ≧300 mg/g) ，micro-albuminuria (UACR: 30 - 300 mg/g))	To see the correlation between diabetes neuropathy (by Q sense measurement) and albuminuria status ( at baseline, 6 months and 12 months). Check the albuminuria status by the criteria (macro-albuminuria (UACR ≧300 mg/g) ，micro-albuminuria (UACR: 30 - 300 mg/g))	month 0,6,12
Peripheral arterial occlusive disease	To see the correlation between diabetes neuropathy (by Q sense measurement) and severity of peripheral arterial occlusive disease ( at baseline, 6 months and 12 months).	month 0,6,12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes foot	To see the correlation between diabetes neuropathy (by Q sense measurement) and diabetes foot, foot ulceration ( at baseline, 6 months and 12 months).	month 0, 6, 12
major lower leg events ( lower leg amputation or revascularization)	To see the correlation between diabetes neuropathy (by Q sense measurement) and major lower leg events including lower leg amputation or revascularization) ( at baseline, 6 months and 12 months).	month 0,6,12
Major cardiac events ( myocardial infarction, strokes and cardiac related death)	To see the correlation between diabetes neuropathy (by Q sense measurement) and major cardiac events including myocardial infarction, strokes and cardiac related death)( at baseline, 6 months and 12 months.	month 0,6,12

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Kuei-Mei Chou, MD, Chang Gung Memorial Hospital, Keelung

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): April 1, 2019
• Study Completion (ANTICIPATED): April 1, 2019

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (ACTUAL): April 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Endocrine System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetes Mellitus; Polyneuropathies
• Other Study ID Numbers: CMRPG2F0171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO