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Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing

Diabetic Foot Clinical Trial

Official title:
Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02052817
Study type Interventional
Source Toad Medical Corporation
Contact Lori Hammer, RN
Phone 216-983-4719
Email lori.hammer@uhhospitals.org
Status Recruiting
Phase N/A
Start date December 2013
View Details
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