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

Diabetic Foot Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01299246
• Other study ID #: 98-2224-B
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: January 30, 2011
• Last updated: February 17, 2011
• Start date: November 2009
• Est. completion date: July 2013

Study information

• Verified date: October 2009
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 386
• Est. completion date: July 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diabetics mellitus patients

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Foot
• Diabetic Nephropathies
• Type 2 Diabetes Mellitus With Established Diabetic Nephropathy

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Graduate Institute of Nursing, Chang Gung Institute of Technology, Chiayi Campus	Chiayi

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No