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The Effectiveness of Improving Self-care After Counseling for the Diabetics Mellitus Foots Around Chiayi Region

Primary Purpose

Diabetic Foot, Type 2 Diabetes Mellitus With Established Diabetic Nephropathy

Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Michigan Neuropathy Screening Instrument
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetic Foot focused on measuring Diabetic Foot, non-invasive DFP assessment tools, early detection of DFP

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diabetics mellitus patients

Sites / Locations

  • Graduate Institute of Nursing, Chang Gung Institute of Technology, Chiayi Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

improving self-care

Arm Description

Outcomes

Primary Outcome Measures

Number of the residents in detecting the early neurovasculopathy
It is shown that using the MNSI and ABI as community screening tools can be useful in detecting the early neurovasculopathy for diabetic rural residents. In addition, where an ABI machine is unavailable, performing MNSI using primary healthcare providers might be cost-effective.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2011
Last Updated
February 17, 2011
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01299246
Brief Title
The Effectiveness of Improving Self-care After Counseling for the Diabetics Mellitus Foots Around Chiayi Region
Official Title
The Effectiveness of Improving Self-care and Health Status After Promoting Counseling for the Diabetics Mellitus Patients With DM Foots Around Yunlin and Chiayi Region
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objectives: Preventing diabetic foot problems (DFP) and associated consequences, such as amputation, is a critical in rural regions. The objective is to present on the association of non-invasive DFP assessment tools and physiological indicators for the early detection of DFP among rural cases of diabetes in Taiwan.
Detailed Description
Peripheral neurological assessment was carried out using Michigan Neuropathy Screening Instrument (MNSI). The diabetes nurse educators assessed five parameters on both feet and counted the total points, ranging from 0 to10: (1) Appearance of feet (normal/abnormal with 0 and 1 point); if abnormal, then inspection of lower limbs for deformities, dry skin, fissure, calluses or infection was carried out; (2) Identification of foot ulceration (yes/no with 0 and 1 point); (3) Vibration perception of the big toe (present/decreased/absent, with 0, 0,5 and 1 points); (4) Ankle reflexes (present/reinforcement/absent, with 0, 0,5 and 1 points); (5) touch-pressure sensation test with a 10 g Semmes-Weinstein monofilament (normal/reduced/absent, with 0, 0,5 and 1 points). When an MNSI summative score was ≥2 points with neuropathy, patients were referred to the teaching hospitals for further evaluation. The MNSI procedures took 6-8 minutes for each participant. Peripheral vascular assessment: three parameters were used to assess peripheral vascular function by trained nurses. (a) The Cardio-Vision Model MS-2000 was used to detect Ankle Brachial Index (ABI), assessed by research nurses. Values of ABI were classified as ≥0.9 normal and <0.9 abnormal. (b) Palpable pedal, posterior tibias and popliteal pulses were recorded as absent, weak or present. (c) Capillary refill time was done by pressing the tip of the toenail for two seconds, and taking the time for the blanched area to turn pink again. If the return time took >2 seconds, this was taken as ischemia. Assessing of all 3 parameters of peripheral vascular assessment took 10-15 minutes for each participant. Diabetic foot risk assessment was assessed by plastic surgeons: (a) King's College classification (KC) contained six stages of condition: not at risk, at risk, ulcer, cellulites, necrosis and amputation. (b) the Texas risk classification (TRC) system was divided into six categories in origin. We re-categorized three levels: low risk, at risk, and high risk. The blood glucose, total cholesterol, and low density of lipoprotein cholesterol were drawn from the last 1-2 month diabetes passport record for each subject. Blood pressure was measured according to standard procedures by the nurses during the study. Body mass index was calculated for each participant using the standard formula (weight in kilograms divided by square of the height in meters). Waist circumference in centimeter was used to measure central obesity, measuring the mid-abdominal distance between the last rib margin and the iliac crest.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Type 2 Diabetes Mellitus With Established Diabetic Nephropathy
Keywords
Diabetic Foot, non-invasive DFP assessment tools, early detection of DFP

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
386 (Actual)

8. Arms, Groups, and Interventions

Arm Title
improving self-care
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Michigan Neuropathy Screening Instrument
Other Intervention Name(s)
Cardio-Vision Model MS-2000 for ABI measurement.
Intervention Description
Peripheral neurological assessment was carried out using MNSI. The diabetes nurse educators assessed five parameters on both feet and counted the total points, ranging from 0 to10: (1) Appearance of feet; if abnormal, then inspection of lower limbs for deformities was carried out; (2) Identification of foot ulceration; (3) Vibration perception of the big toe; (4) Ankle reflexes; (5) touch-pressure sensation test with a 10 g Semmes-Weinstein monofilament.
Primary Outcome Measure Information:
Title
Number of the residents in detecting the early neurovasculopathy
Description
It is shown that using the MNSI and ABI as community screening tools can be useful in detecting the early neurovasculopathy for diabetic rural residents. In addition, where an ABI machine is unavailable, performing MNSI using primary healthcare providers might be cost-effective.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diabetics mellitus patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Yen Chen, Ph.D.
Organizational Affiliation
Graduate Institute of Nursing, Chang Gung Institute of Technology, Chiayi Campus, Taiwan. Tel: 886 (5) 3628800 ext. 2201, Fax: 886-5-3628866, Email: meiyen@gw.cgit.edu.tw
Official's Role
Study Chair
Facility Information:
Facility Name
Graduate Institute of Nursing, Chang Gung Institute of Technology, Chiayi Campus
City
Chiayi
ZIP/Postal Code
61363
Country
Taiwan

12. IPD Sharing Statement

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The Effectiveness of Improving Self-care After Counseling for the Diabetics Mellitus Foots Around Chiayi Region

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