Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Tele-foot X
Brief Summary:
The purpose of the study is design and use a telemedicine platform which integrates video-chat pre-programmed interactive game-based foot and ankle exercise modules and real-time quantitative performance metrics displayed to the clinician to improve patients perfusion to the lower extremity improve diabetic wound healing and prevent muscle loss in the lower extremityThis is a cross sectional and comparative feasibility study It is designed to explore acceptability feasibility and proof of concept
Detailed Description:
Foot ulceration is the most common and costly late complication of diabetes with morbidity and mortality being worse than many cancers It is estimated that up to one-third of people with diabetes will develop a diabetic foot ulcer DFU in their lifetime Non-healing DFUs are a leading cause of hospitalization amputation disability and death among people with diabetes In the United States one-third of all diabetes-related costs are spent on diabetic foot care with two-thirds of the costs incurred in inpatient settings constituting a substantial economic burden to society Therefore every means possible should be used to try to heal DFU and prevent amputation In this regard there is a significant body of evidence related to the clinical benefits of exercise for people with DFU including improving blood flow and oxygen supply muscle loss prevention and joint mobility Despite this evidence exercise is not part of the standard care for wound healing mainly because there is no solution for promoting and managing home-based exercise programs for people with DFU
To address the gaps described above we propose an interactive foot and ankle tele-exercise platform called Tele-FootX This platform allows clinicians to remotely and virtually supervise exercise tasks and coach patients to perform evidence-based foot and ankle exercises inspired by the validated Buerger-Allen BA while also educating and monitoring the patients adherence to the exercise program
To address the gaps described above we propose an interactive foot and ankle tele-exercise platform called Tele-FootX This platform allows clinicians to remotely and virtually supervise exercise tasks and coach patients to perform evidence-based foot and ankle exercises inspired by the validated Buerger-Allen BA while also educating and monitoring the patients adherence to the exercise program
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