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

ConditionDiabetic Foot
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorKing Abdullah University Hospital

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 volunteers

Qualifiers

Adults DM (1 year)

Disqualifiers

Cognitive impairment

Trial population

DM patients

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: DM with DFU1 intervention
Group B: DM without DFU0 interventions

Trial outcomes

Primary outcomes

1

Number of diabetic patients without diabetic foot ulcers

Patients diagnosed with DM and have no reported DFU

Time frame
8 weeks
2

Number of patients with diabetic foot ulcers

Patients diagnosed with DM and have been diagnosed with DFU

Time frame
8 weeks
3

Number of patients receiving diabetic foot care education

Patients diagnosed with DM and received diabetic foot care education

Time frame
8 weeks

Secondary outcomes

1

Number of patients reporting good foot care practices

Patients diagnosed with DM and DFU

Time frame
8 weeks
2

Number of patients reporting Medication adherence

Patients diagnosed with DM and DFU

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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