Skip to main content
Clinical Trials/NCT06578689
NCT06578689
Recruiting
N/A

Factors and Consequences Associated With Diabetic Foot Problems Among Diabetic Patients in Jordan

King Abdullah University Hospital1 site in 1 country200 target enrollmentJanuary 1, 2024
ConditionsDiabetic Foot

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetic Foot
Sponsor
King Abdullah University Hospital
Enrollment
200
Locations
1
Primary Endpoint
Number of patients with diabetic foot ulcers
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Purpose: To assess diabetic foot ulcers (DFU)-related risk factors and complications among diabetes mellitus (DM) patients in Northern Jordan. Also, to analyze the impact of educational intervention on their behavior.

Methods: The study consisted of two phases. Phase one was a prospective cross-sectional study of 200 DM patients, including 94 with a history of DFU, where demographic and clinical data were collected to assess diabetic foot-associated risk factors and complications. Phase two was a randomized clinical trial with 105 DM patients: 52 in the control group received standard care, while 53 in the intervention group received standard care supplemented with formal educational session and ongoing foot care education via mobile health by a clinical pharmacist. Foot care practices and medication adherence were evaluated at baseline and after 8 weeks of follow-up.

Detailed Description

Background: Diabetes mellitus (DM) is a common chronic metabolic condition with numerous consequences, including diabetic foot ulcers. diabetic foot ulcer (DFU) is the major cause of non-traumatic lower extremity amputations. DFU is linked to several risk factors, including a lack of information and inadequate foot care practices. In Jordan, statistics on diabetic foot are few, with no evidence of the impact of patient education on disease outcomes. Aims: To assess DFU-related risk factors and complications among DM patients in Northern Jordan. Also, analyze the impact of educational intervention on their behavior. Methods: A prospective cross-sectional sample of 200 DM patients, including 94 with a history of DFU was initially selected. Subsequently, a smaller cohort of 105 patients was randomized into either a control group or an intervention group after providing written informed consent. The control group received standard care, while the intervention group received standard care supplemented with formal educational session followed by ongoing education on foot care using mobile health by a clinical pharmacist. Diabetic foot-associated risk factors and complications were assessed. Foot care practices and medication adherence were evaluated for both the control and intervention groups at baseline and again after 8 weeks of follow-up. Binary logistic regression was employed to assess factors associated with DFU. The Chi-square test and independent sample t-test were used to compare the behavior between the two groups before and after the intervention.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Samah Al-Shatnawi

Associate Professor

King Abdullah University Hospital

Eligibility Criteria

Inclusion Criteria

  • Adults DM (1 year)
  • Have a mobile phone

Exclusion Criteria

  • Cognitive impairment

Outcomes

Primary Outcomes

Number of patients with diabetic foot ulcers

Time Frame: 8 weeks

Patients diagnosed with DM and have been diagnosed with DFU

Number of diabetic patients without diabetic foot ulcers

Time Frame: 8 weeks

Patients diagnosed with DM and have no reported DFU

Number of patients receiving diabetic foot care education

Time Frame: 8 weeks

Patients diagnosed with DM and received diabetic foot care education

Secondary Outcomes

  • Number of patients reporting Medication adherence(8 weeks)
  • Number of patients reporting good foot care practices(8 weeks)

Study Sites (1)

Loading locations...

Similar Trials