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| Name | Class |
|---|---|
| University Hospitals Cleveland Medical Center | OTHER |
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The TOAD Medical Corporation Brace is a novel device that completely off-loads the foot and has been shown to heal ulcers at a rapid rate in preliminary experience in patients with plantar ulcers. This trial will attempt to show the efficacy of the Toad Brace and is based on the hypothesis that the Toad brace completely offloads the foot and hastens healing rates of diabetic ulcers. The trial will randomize 74 patients with diabetic pedal ulcers to the Toad Brace or conventional therapy. . Quantitative assessment of ulcer rate healing rates will be determined clinically and by blinded, computer-assisted planimetry of digital images over a 12 week period. The pressure on the plantar surface will be measured via a pressure sensor in a subset of patients. The trials will attempt to show markedly reduced pressure on the plantar surface and significantly higher ulcer healing rates with using the Toad Brace.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Debridement and standard of care in off-loading on control patients |
|
| Toad Brace | Experimental | Debridement and fitting of Toad Brace |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimal Medical Therapy Debridement + Toad Brace | Device |
| ||
| Optimal Medical Therapy - Debridement |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline measured wound area | We are taking repeated measures of wound area healing for pedal ulcers over a period of 12 weeks. | Every 3 weeks for a period of 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lori Hammer, RN | Contact | 216-983-4719 | lori.hammer@uhhospitals.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Hospitals of Cleveland d/b/a University Hospitals Case Medical | Recruiting | Cleveland | Ohio | 44106 | United States |
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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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| Other |
|
| 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 |