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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03356041
Other study ID # Hawler Med University
Secondary ID
Status Recruiting
Phase N/A
First received November 17, 2017
Last updated November 22, 2017
Start date December 20, 2017
Est. completion date March 23, 2018

Study information

Verified date November 2017
Source Hawler Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aims of this study are to determine the prevalence of diabetic peripheral neuropathy among the diabetic patients, to determine the association between the clinical profiles of the diabetic patients (diabetes type, diabetes duration, HbA1c, body mass index, hypertension, total cholesterol) and the diabetic peripheral neuropathy DPN and the rational poly pharmacy used to control pain.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 23, 2018
Est. primary completion date March 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion criteria

1. Aged 18 years or older.

2. Both sex.

3. Diagnosed with type 2 diabetes at least one year previously.

4. Took at least one prescribed medication for diabetes.

5. Diagnosed as diabetic peripheral neuropathy based on clinical

Exclusion Criteria:

1. History of alcohol consumption.

2. Thyroid gland disorder.

3. Any kidney disorder.

4. Any conditions that could confound assessment of pain due to diabetic peripheral neuropathy.

5. Have foot injury or open sore.

6. Pregnant females or who plan to become pregnant during the study period.

7. Any serious medical condition that might prevent completion or hinder compliance with exercise.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Diabetic patients with neuropathy
Lifestyle modification will be assessed using summary of diabetes self-care activity

Locations

Country Name City State
Iraq Prof. Kawa Dizaye Erbil

Sponsors (1)

Lead Sponsor Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estimating Summary of diabetes self-care activity (SDSCA) Assessing Lifestyle modification by summary of diabetes self-care activity (SDSCA) at baseline visit and after three months for both Intervention patients and usual care group Increases in the means of the items of the scale as Exercise, Blood sugar testing, Specific diet and Foot care in the intervention group. Three months
Primary Adherence to treatment according to Morisky scale Morisky scale is used to assess medication adherence at baseline visit and after three months for both Intervention patients and usual care group.
Improving the patient medication adherence behavior in the intervention group patients
Three months
Primary Douleur Neuropathique 4 (DN4), Neuropathic Pain Scale (NPS), Reduction in the percent of response of patients feeling; electric shock, tingling, and pin needle after the lifestyle modification in the intervention group. Three months
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