The Early Intervention and Prevention of Diabetes Foot

NCT03133819 | Unknown DMC

• 1 other identifier: CMRPG2F0171
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes; Neuropathy, Polyneuropathy (Manifestation)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Diabetes foot

  month 0, 6, 12

• major lower leg events ( lower leg amputation or revascularization)

  month 0,6,12

• Major cardiac events ( myocardial infarction, strokes and cardiac related death)

  month 0,6,12

Study Arms (1)

Q-Sense_QST (TSA II)

OTHER

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)

Interventions

Q-Sense_QST (TSA II) DEVICE

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.

Q-Sense_QST (TSA II)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus; Polyneuropathies

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Kuei-Mei Chou, MD

  Chang Gung Memorial Hospital, Keelung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: April 28, 2017
• Study Start: November 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 8, 2017

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share