An interventional study of Optimal Medical Therapy Debridement + Toad Brace and Optimal Medical Therapy - Debridement in Diabetic Foot and Pedal Ulcers, sponsored by Toad Medical Corporation. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-03.
Sponsored by Toad Medical Corporation · Not applicable, Interventional, and Treatment
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 74 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →This is the only study on the registry with Toad Medical Corporation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Debridement and standard of care in off-loading on control patients
Other: Optimal Medical Therapy - Debridement
Debridement and fitting of Toad Brace
Device: Optimal Medical Therapy Debridement + Toad Brace
Change 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
This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.