Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Toad Medical Corporation
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Change from baseline measured wound area
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Control
Debridement and standard of care in off-loading on control patients
Intervention: Optimal Medical Therapy - Debridement (Other)
Toad Brace
Debridement and fitting of Toad Brace
Intervention: Optimal Medical Therapy Debridement + Toad Brace (Device)
Outcomes
Primary Outcomes
Change from baseline measured wound area
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported