The Early Intervention and Prevention of Diabetes Foot

Diabetes; Neuropathy, Polyneuropathy (Manifestation) Clinical Trial

Official title:

The Early Intervention and Prevention of Diabetes Foot

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03133819
• Other study ID #: CMRPG2F0171
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 10, 2017
• Last updated: May 4, 2017
• Start date: November 2016
• Est. completion date: April 2019

Study information

• Verified date: May 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes; Neuropathy, Polyneuropathy (Manifestation)
• Diabetic Neuropathies
• Polyneuropathies

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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