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

NCT01299246 | Unknown Phase 1 DMC

• 1 other identifier: 98-2224-B
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Type 2 Diabetes Mellitus With Established Diabetic Nephropathy

Keywords

Diabetic Foot; non-invasive DFP assessment tools; early detection of DFP

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

improving self-care

EXPERIMENTAL

Procedure: Michigan Neuropathy Screening Instrument

Interventions

Michigan Neuropathy Screening Instrument PROCEDURE

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.

Also known as: Cardio-Vision Model MS-2000 for ABI measurement.

improving self-care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetics mellitus patients

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

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

Chiayi City, 61363, Taiwan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 30, 2011
• First Posted: February 18, 2011
• Study Start: November 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: July 1, 2013
• Last Updated: February 18, 2011

Record last verified: 2009-10

Locations

TW (1)