Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2013 |
| Contact: | Lori Hammer, RN |
| Email: | lori.hammer@uhhospitals.org |
| Phone: | 216-983-4719 |
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.
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.
Inclusion Criteria:
- Men or women >18 years old
- One or more foot ulcers without clinical evidence of osteomyelitis
- Diagnosis of Diabetes Mellitus*
- University of Texas Grade 1A, 1C, 2A, or 2C ulcer15
- ABI >0.7 and Toe pressure >30mmHg
Exclusion Criteria:
- Limited life-expectancy
- Wounds on calf or shin that would be in contact with the TAG Brace
- Gangrene, active infection
- Osteomyelitis of the foot with the ulcer
- Chronically bedridden/Non ambulatory
- Unable to keep research appointments
- Wide spread malignancy or systemically immunocompromising disease
- Ipsilateral revascularization procedure within the last 30 days.
- Unreliable, unwilling or unable to comprehend informed consent
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