Clinical trial NCT01299246: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetic Foot
Type 2 Diabetes Mellitus With Established Diabetic Nephropathy
Keywords: Diabetic Foot
non-invasive DFP assessment tools
early detection of DFP
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 386
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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: 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 criteria: Inclusion Criteria:

* diabetics mellitus patients

Primary outcomes:
measure: Number of the residents in detecting the early neurovasculopathy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chiayi
country: Taiwan
facility: Graduate Institute of Nursing, Chang Gung Institute of Technology, Chiayi Campus
Study officials:
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
name: Mei-Yen Chen, Ph.D.
role: STUDY_CHAIR
References: