Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578689
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Factors and Consequences Associated With Diabetic Foot Problems Among Diabetic Patients in Jordan
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Factors and Consequences Associated With Diabetic Foot Problems Among Diabetic Patients in Jordan
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None