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The United States Department of Veterans Affairs spends an estimated $1.5 billion a year on healthcare for patients with diabetes. The prevalence and complications of diabetes increase with age. Therefore, with the aging of the US and Veteran populations, there is an expectation of increased healthcare costs associated with treating diabetes and the associated complications of this disorder. One common complication is the diabetic foot ulcer. Diabetic foot ulcers are expensive to treat, can take a long time to heal and result in a decrease in patient quality of life. Patients remain susceptible to developing more foot ulcers over time. The goal of this project is to reduce the time it takes to heal a diabetic foot ulcer, increase the time between episodes of ulceration and improve the quality of life for diabetic foot ulcer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Patients will be given additional counseling |
|
| Control group | Active Comparator | Patients will be given standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Removable cam walker boot | Device | Standard of care device given to diabetic foot ulcer patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Orthosis wear-time | The total time that the orthosis has been worn between clinic visits. | At each clinic visit through study completion, an average of 8 months |
| Foot ulcer size | Size of the diabetic foot ulcer. | At each clinic visit through study completion, an average of 8 months |
| Foot ulcer healing status | Status of the diabetic foot ulcer. | At each clinic visit through study completion, an average of 8 months |
| Number of foot ulcers | The number of diabetic foot ulcers. | At each clinic visit through study completion, an average of 8 months |
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Inclusion Criteria:
Exclusion Criteria:
Veteran patients with amputation proximal to the tarsometatarsal joint, with a Meggitt-Wagner score of 4 or more, with severe infection, with non-ambulatory status or without palpable pedal pulse will be excluded
All patients will be screened for severe cognitive impairment with the 15 point Brief Interview for Mental Status (BIMS)
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| Name | Affiliation | Role |
|---|---|---|
| Muturi G. Muriuki, PhD | Edward Hines Jr. VA Hospital, Hines, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | 60612 | United States | ||
| Edward Hines Jr. VA Hospital, Hines, IL |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 9, 2022 | Jun 4, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Counseling | Other | Additional education, counseling and encouragement of use of the orthosis beyond the current standard of care. |
|
| Hines |
| Illinois |
| 60141-3030 |
| United States |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D005159 | Health Care Facilities Workforce and Services |