Clinical trial NCT06578689: Factors and Consequences Associated With Diabetic Foot Problems Among Diabetic Patients in Jordan
Official title: Factors and Consequences Associated With Diabetic Foot Problems Among Diabetic Patients in Jordan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Foot
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DM patients

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.

Eligibility criteria: Inclusion Criteria:

* Adults DM (1 year)

Have a mobile phone

Exclusion Criteria:

* Cognitive impairment

Primary outcomes:
measure: Number of diabetic patients without diabetic foot ulcers
timeFrame: 8 weeks
measure: Number of patients with diabetic foot ulcers
timeFrame: 8 weeks
measure: Number of patients receiving diabetic foot care education
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of patients reporting good foot care practices
timeFrame: 8 weeks
measure: Number of patients reporting Medication adherence
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
References: