Jordan University of Science and Technology
Irbid, Jordan
Location status: Recruiting
NCT Number: NCT06578689
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Irbid, Jordan
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Have a mobile phone
Exclusion criteria
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.
Time frame: 8 weeks
Patients diagnosed with DM and have no reported DFU
Time frame: 8 weeks
Patients diagnosed with DM and have been diagnosed with DFU
Time frame: 8 weeks
Patients diagnosed with DM and received diabetic foot care education
Time frame: 8 weeks
Patients diagnosed with DM and DFU
Time frame: 8 weeks
Patients diagnosed with DM and DFU
King Abdullah University Hospital
Other
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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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