UnknownNot Applicable

The Early Intervention and Prevention of Diabetes Foot

400 participantsStarted 2016-11

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Glycohemoglobin (HbA1c)

Timeframe: month 0, 6, 12

Lipid profile

Timeframe: month 0,6,12

Diabetes nephropathy ( macro-albuminuria (UACR ≧300 mg/g) ，micro-albuminuria (UACR: 30 - 300 mg/g))

Timeframe: month 0,6,12

Peripheral arterial occlusive disease

Timeframe: month 0,6,12

Trial details

NCT IDNCT03133819

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04

View on ClinicalTrials.gov More Diabetes; Neuropathy, Polyneuropathy (Manifestation) trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.