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

NCT06578689 | Recruiting

• 1 other identifier: 20240097
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (3)

• Number of diabetic patients without diabetic foot ulcers

  Patients diagnosed with DM and have no reported DFU

  8 weeks

• Number of patients with diabetic foot ulcers

  Patients diagnosed with DM and have been diagnosed with DFU

  8 weeks

• Number of patients receiving diabetic foot care education

  Patients diagnosed with DM and received diabetic foot care education

  8 weeks

Secondary Outcomes (2)

• Number of patients reporting good foot care practices

  8 weeks

• Number of patients reporting Medication adherence

  8 weeks

Study Arms (2)

DM with DFU

Behavioral: Education

DM without DFU

Interventions

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.

DM with DFU

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

DM patients

You may qualify if:

• Adults DM (1 year)
• Have a mobile phone

You may not qualify if:

• Cognitive impairment

Sponsors & Collaborators

• King Abdullah University Hospital: lead

Study Sites (1)

Jordan University of Science and Technology

Irbid, Jordan

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 29, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

JO (1)