Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487780
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People with diabetes often experience foot ulcers which can harm their ability to move lower their quality of life and increase the chances of losing a limb These diabetic foot ulcers DFUs commonly come back recur even after theyve healed so its crucial to stop them from returning to avoid toe foot or leg amputation While wearing special shoes to reduce pressure on the feet is essential for healing and preventing DFUs many people struggle to follow this treatment plan once their ulcers have healed This study aims to see if a lifestyle-focused program can help participants create daily routines and habits that make it easier to consistently use special shoes and take care of their diabetes and feet to prevent ulcers from recurring
Detailed Description:
Diabetic foot ulcers DFUs are a significant complication of diabetes responsible for 80 of lower extremity amputations in the United States and posing a substantial burden on patients and society Despite treatment up to 23 of DFUs remain unhealed at 12 months with recurrence rates of 40 within a year and 65 within three years Proper offloading of foot pressure and glucose control is crucial for preventing recurrent DFUs especially in cases of neuropathy While standard clinical practice includes patient education and therapeutic footwear prescription adherence to offloading treatment often falls short due to non-medical factors such as insufficient understanding and difficulties integrating offloading into daily routines To tackle these challenges we propose a lifestyle-focused intervention conducted by trained occupational therapist OT aiming at fostering consistent self-care habits and routinesThe objective of this pilot trial is to evaluate the feasibility acceptability of a lifestyle-focused OT intervention for enhancing offloading treatment in high-risk individuals with a history of healed DFUs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None