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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot
• Intervention / Treatment: Behavioral: Education

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan
    • Recruiting
    • Jordan University of Science and Technology
    • Contact: Samah Al-Shatnawi, PhD; Phone Number: 00962790743896; Email: sfshatnawi@just.edu.jo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

DM patients

Description

Inclusion Criteria:

• Adults DM (1 year)

Have a mobile phone

Exclusion Criteria:

• Cognitive impairment

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DM with DFU	Behavioral: Education; 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.
DM without DFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of diabetic patients without diabetic foot ulcers	Patients diagnosed with DM and have no reported DFU	8 weeks
Number of patients with diabetic foot ulcers	Patients diagnosed with DM and have been diagnosed with DFU	8 weeks
Number of patients receiving diabetic foot care education	Patients diagnosed with DM and received diabetic foot care education	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients reporting good foot care practices	Patients diagnosed with DM and DFU	8 weeks
Number of patients reporting Medication adherence	Patients diagnosed with DM and DFU	8 weeks

Collaborators and Investigators

• Sponsor: King Abdullah University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: 20240097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data was collected anonyms and coded

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No