About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults DM (1 year)
Disqualifiers
Cognitive impairment
Trial population
DM patients
Trial design
Case-control
Prospective
Treatments tested in this trial
Education
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Number of diabetic patients without diabetic foot ulcers
Patients diagnosed with DM and have no reported DFU
Number of patients with diabetic foot ulcers
Patients diagnosed with DM and have been diagnosed with DFU
Number of patients receiving diabetic foot care education
Patients diagnosed with DM and received diabetic foot care education
Secondary outcomes
Number of patients reporting good foot care practices
Patients diagnosed with DM and DFU
Number of patients reporting Medication adherence
Patients diagnosed with DM and DFU
Sponsors and contacts
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