Diabetic Foot, Pedal Ulcers
Conditions
Brief 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.
Interventions
DEVICEOptimal Medical Therapy Debridement + Toad Brace
OTHEROptimal Medical Therapy - Debridement
Sponsors
University Hospitals Cleveland Medical Center
Toad Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline measured wound area | Every 3 weeks for a period of 12 weeks | We are taking repeated measures of wound area healing for pedal ulcers over a period of 12 weeks. |
Countries
United States
Contacts
Primary ContactLori Hammer, RN
Outcome results
None listed