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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
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes; Neuropathy, Polyneuropathy (Manifestation)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 10, 2017
    Last Updated
    May 4, 2017
    Sponsor
    Chang Gung Memorial Hospital
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    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

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