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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01299246
First received: January 30, 2011
Last updated: February 17, 2011
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Foot
Type 2 Diabetes Mellitus With Established Diabetic Nephropathy
 Procedure: Michigan Neuropathy Screening Instrument
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Number of the residents in detecting the early neurovasculopathy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 386
Study Start Date: November 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: improving self-care Procedure: Michigan Neuropathy Screening Instrument
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.
Other Name: Cardio-Vision Model MS-2000 for ABI measurement.

Detailed Description:
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diabetics mellitus patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299246

Locations
Taiwan
Graduate Institute of Nursing, Chang Gung Institute of Technology, Chiayi Campus
Chiayi, Taiwan, 61363
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Chair: Mei-Yen Chen, Ph.D. 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
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01299246     History of Changes
Other Study ID Numbers: 98-2224-B
Study First Received: January 30, 2011
Last Updated: February 17, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Diabetic Foot
non-invasive DFP assessment tools
early detection of DFP

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Diabetic Foot
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
 Diabetes Complications
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 19, 2013