NCT02052817

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Toad Medical Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot
• Pedal Ulcers

Interventions

Type	Name	Description
DEVICE	Optimal Medical Therapy Debridement + Toad Brace
OTHER	Optimal Medical Therapy - Debridement

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-05-01
• First posted: 2014-02-03
• Last updated: 2014-02-03

Locations

1 site across 1 country: United States