Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312579
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-28
Brief Title:
At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Home-based Exercise to Improve Functional Outcomes in Veterans With Recently Healed Diabetic Foot Ulcer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Foot ulcers and amputations are a common and feared complication for people with diabetes People with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer At least one in four people with a new diabetic foot ulcer will die within five years largely due to cardiovascular causes The reasons for this increased mortality involve decreased mobility
People with a recently healed diabetic foot ulcer are considered in remission as opposed to cured because the underlying medical problems which led to their ulcer are still present Once in remission the current standard of care is to slowly increase ambulation The problem is that people rarely return to the recommended level of mobility The ability to safely maintain mobility with aging is critical
This pilot study is a small clinical trial to test the feasibility and acceptability of a home-based exercise regimen The investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving lower extremity strength lower extremity tissue perfusion and glycemic control
People with a recently healed diabetic foot ulcer are considered in remission as opposed to cured because the underlying medical problems which led to their ulcer are still present Once in remission the current standard of care is to slowly increase ambulation The problem is that people rarely return to the recommended level of mobility The ability to safely maintain mobility with aging is critical
This pilot study is a small clinical trial to test the feasibility and acceptability of a home-based exercise regimen The investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving lower extremity strength lower extremity tissue perfusion and glycemic control
Detailed Description:
Population 25 Veterans with a healed foot ulcer in the last 3-15 months
Site VA Maryland Health Care System VAMHCS
Study Duration Approximately 2 years
Study Design Randomized outcome assessor blinded clinical trial comparing a a 12-week home-based exercise regimen to b standard of care
Objectives
Primary To assess the feasibility and acceptability of the intervention
Secondary
The effect of the intervention on gait speed
The effect of the intervention on other measures of mobility and function including six-minute walk distance the Modified Physical Performance Test steps per day and community mobility and
The effect of the intervention on lower extremity strength perfusion of the foot and glycemic control
Treatment Regimens 12-week home-based exercise regimen to standard of care
Duration of Participants Participation Up to 16 weeks
Site VA Maryland Health Care System VAMHCS
Study Duration Approximately 2 years
Study Design Randomized outcome assessor blinded clinical trial comparing a a 12-week home-based exercise regimen to b standard of care
Objectives
Primary To assess the feasibility and acceptability of the intervention
Secondary
The effect of the intervention on gait speed
The effect of the intervention on other measures of mobility and function including six-minute walk distance the Modified Physical Performance Test steps per day and community mobility and
The effect of the intervention on lower extremity strength perfusion of the foot and glycemic control
Treatment Regimens 12-week home-based exercise regimen to standard of care
Duration of Participants Participation Up to 16 weeks
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?:
False
Is an FDA AA801 Violation?:
None