The Early Intervention and Prevention of Diabetes Foot
Primary Purpose
Diabetes; Neuropathy, Polyneuropathy (Manifestation)
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Q-Sense_QST (TSA II)
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes; Neuropathy, Polyneuropathy (Manifestation)
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Q-Sense_QST (TSA II)
Arm Description
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.
Outcomes
Primary Outcome Measures
Glycohemoglobin (HbA1c)
To see the correlation between diabetes neuropathy (by Q sense measurement) and glycemic control status ( at baseline, 6 months and 12 months).
Lipid profile
To see the correlation between diabetes neuropathy (by Q sense measurement) and lipid profile ( at baseline, 6 months and 12 months).
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))
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).
Secondary Outcome Measures
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).
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).
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.
Full Information
NCT ID
NCT03133819
First Posted
January 10, 2017
Last Updated
May 4, 2017
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03133819
Brief Title
The Early Intervention and Prevention of Diabetes Foot
Official Title
The Early Intervention and Prevention of Diabetes Foot
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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 (+), but no foot ulceration
Group 4: 100 diabetes patients with neuropathy, PAOD(+) , and foot ulceration QST will perform using the Medoc device (TSA2001/VSA3001) following previous published procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes; Neuropathy, Polyneuropathy (Manifestation)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Q-Sense_QST (TSA II)
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Q-Sense_QST (TSA II)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycohemoglobin (HbA1c)
Description
To see the correlation between diabetes neuropathy (by Q sense measurement) and glycemic control status ( at baseline, 6 months and 12 months).
Time Frame
month 0, 6, 12
Title
Lipid profile
Description
To see the correlation between diabetes neuropathy (by Q sense measurement) and lipid profile ( at baseline, 6 months and 12 months).
Time Frame
month 0,6,12
Title
Diabetes nephropathy ( macro-albuminuria (UACR ≧300 mg/g) ,micro-albuminuria (UACR: 30 - 300 mg/g))
Description
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))
Time Frame
month 0,6,12
Title
Peripheral arterial occlusive disease
Description
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).
Time Frame
month 0,6,12
Secondary Outcome Measure Information:
Title
Diabetes foot
Description
To see the correlation between diabetes neuropathy (by Q sense measurement) and diabetes foot, foot ulceration ( at baseline, 6 months and 12 months).
Time Frame
month 0, 6, 12
Title
major lower leg events ( lower leg amputation or revascularization)
Description
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).
Time Frame
month 0,6,12
Title
Major cardiac events ( myocardial infarction, strokes and cardiac related death)
Description
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.
Time Frame
month 0,6,12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuei-Mei Chou, MD
Organizational Affiliation
Chang Gung Memorial Hospital, Keelung
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Early Intervention and Prevention of Diabetes Foot
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