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NCT Number: NCT06578689

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jordan University of Science and Technology

Irbid, Jordan

Location status: Recruiting

Location contact

Samah Al-Shatnawi, PhD

CONTACT

[email protected]

00962790743896

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults DM (1 year)

Have a mobile phone

Exclusion criteria

  • Cognitive impairment

Treatment and study plan

Education

Behavioral

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.

Primary outcomes

  1. Number of diabetic patients without diabetic foot ulcers

    Time frame: 8 weeks

    Patients diagnosed with DM and have no reported DFU

  2. Number of patients with diabetic foot ulcers

    Time frame: 8 weeks

    Patients diagnosed with DM and have been diagnosed with DFU

  3. Number of patients receiving diabetic foot care education

    Time frame: 8 weeks

    Patients diagnosed with DM and received diabetic foot care education

Secondary outcomes

  1. Number of patients reporting good foot care practices

    Time frame: 8 weeks

    Patients diagnosed with DM and DFU

  2. Number of patients reporting Medication adherence

    Time frame: 8 weeks

    Patients diagnosed with DM and DFU

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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