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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
UH Hospitals of Cleveland d/b/a University Hospitals Case Medical
Cleveland, Ohio, United States
RECRUITINGChange from baseline measured wound area
We are taking repeated measures of wound area healing for pedal ulcers over a period of 12 weeks.
Time frame: Every 3 weeks for a period of 12 weeks
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