Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032864
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2002-04-04
Brief Title:
Clinical Trial of Footwear in Patients With Diabetes
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Clinical Trial of Footwear in Patients With Diabetes
Status:
COMPLETED
Status Verified Date:
2003-02
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:
A Seattle VA study indicated lower extremity ulcers preceded 84 of diabetic amputations Nearly half of the events that ban the causal chain leading to ulcers and amputation were initiated by ill-fitting footwear Other investigators report similar findings for injurious footwear in their diabetic patient populations Yet the efficacy of footwear in preventing ulcers and amputations in the high-risk diabetic population has received limited experimental investigation A British descriptive study followed diabetic patients with healed foot ulcers for two years and found reulceration occurred in 72 of patients who resume wearing their own footwear compared to 26 of patients who continued wearing prescribed footwear A Swedish cohort study identified individuals with a foot ulcer and reported their 1 3 and 5 year reulceration rates at 34 61 and 70 respectively without further specifying footwear components In a German diabetic population the reulceration rate was 87 in-patients who abandoned their custom shoes and resumed wearing their own shoes compared to 42 of those who continued to wear their custom shoes Unfortunately none of these studies compared the single or combined contribution of therapeutic shoes or insoles on foot ulcer prevention Nor did these studies address patient adherence to prescribed footwear thus the actual efficacy of various footwear interventions in foot ulcer prevention in this high-risk population is still to be tested
Detailed Description:
Primary Objective
Half of the 7646 amputations performed in VA in 1996 were in veterans with diabetes Lower extremity ulcers preceded about 85 of diabetic amputations Minor trauma often footwear or repetitive pressure related initiated the majority of the ulcers Persons with diabetes have unique footwear needs In 1997 Gayle E Reiber MPH PhD and Douglas G Smith MD of the VA Puget Sound Health Care System initiated a randomized clinical trial 1 to determine the extent to which study shoes and study inserts would reduce the incidence of re-ulceration in diabetic individuals with a prior foot ulcer history and 2 to estimate costs of ulcer prevention using these strategies A total of 400 patients from the VA Puget Sound Health Care System n189 and a Seattle-area Health Maintenance Organization Group Health Cooperative n211 have now been randomized to one of three study arms Arm 1 n120 study shoes and customized cork inserts Arm 2 n119 study shoes and generic polyurethane inserts and Arm 3 n161 controls who are wearing their own footwear Patients in Arms 1 and 2 received formal leisure and athletic shoes built to study specifications by Cole-Haan for men and by Lowell Shoe for women Patients will be followed for two years to determine the incidence and cost of foot re-ulceration
Study Abstract
A Seattle VA study indicated lower extremity ulcers preceded 84 of diabetic amputations Nearly half of the events that ban the causal chain leading to ulcers and amputation were initiated by ill-fitting footwear Other investigators report similar findings for injurious footwear in their diabetic patient populations Yet the efficacy of footwear in preventing ulcers and amputations in the high-risk diabetic population has received limited experimental investigation A British descriptive study followed diabetic patients with healed foot ulcers for two years and found reulceration occurred in 72 of patients who resume wearing their own footwear compared to 26 of patients who continued wearing prescribed footwear A Swedish cohort study identified individuals with a foot ulcer and reported their 1 3 and 5 year reulceration rates at 34 61 and 70 respectively without further specifying footwear components In a German diabetic population the reulceration rate was 87 in-patients who abandoned their custom shoes and resumed wearing their own shoes compared to 42 of those who continued to wear their custom shoes Unfortunately none of these studies compared the single or combined contribution of therapeutic shoes or insoles on foot ulcer prevention Nor did these studies address patient adherence to prescribed footwear thus the actual efficacy of various footwear interventions in foot ulcer prevention in this high-risk population is still to be tested
Half of the 7646 amputations performed in VA in 1996 were in veterans with diabetes Lower extremity ulcers preceded about 85 of diabetic amputations Minor trauma often footwear or repetitive pressure related initiated the majority of the ulcers Persons with diabetes have unique footwear needs In 1997 Gayle E Reiber MPH PhD and Douglas G Smith MD of the VA Puget Sound Health Care System initiated a randomized clinical trial 1 to determine the extent to which study shoes and study inserts would reduce the incidence of re-ulceration in diabetic individuals with a prior foot ulcer history and 2 to estimate costs of ulcer prevention using these strategies A total of 400 patients from the VA Puget Sound Health Care System n189 and a Seattle-area Health Maintenance Organization Group Health Cooperative n211 have now been randomized to one of three study arms Arm 1 n120 study shoes and customized cork inserts Arm 2 n119 study shoes and generic polyurethane inserts and Arm 3 n161 controls who are wearing their own footwear Patients in Arms 1 and 2 received formal leisure and athletic shoes built to study specifications by Cole-Haan for men and by Lowell Shoe for women Patients will be followed for two years to determine the incidence and cost of foot re-ulceration
Study Abstract
A Seattle VA study indicated lower extremity ulcers preceded 84 of diabetic amputations Nearly half of the events that ban the causal chain leading to ulcers and amputation were initiated by ill-fitting footwear Other investigators report similar findings for injurious footwear in their diabetic patient populations Yet the efficacy of footwear in preventing ulcers and amputations in the high-risk diabetic population has received limited experimental investigation A British descriptive study followed diabetic patients with healed foot ulcers for two years and found reulceration occurred in 72 of patients who resume wearing their own footwear compared to 26 of patients who continued wearing prescribed footwear A Swedish cohort study identified individuals with a foot ulcer and reported their 1 3 and 5 year reulceration rates at 34 61 and 70 respectively without further specifying footwear components In a German diabetic population the reulceration rate was 87 in-patients who abandoned their custom shoes and resumed wearing their own shoes compared to 42 of those who continued to wear their custom shoes Unfortunately none of these studies compared the single or combined contribution of therapeutic shoes or insoles on foot ulcer prevention Nor did these studies address patient adherence to prescribed footwear thus the actual efficacy of various footwear interventions in foot ulcer prevention in this high-risk population is still to be tested
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: