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

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.

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

Conditions
-----------------
Diabetic Foot, Pedal Ulcers

Intervention / Treatment
-----------------
* Device: Optimal Medical Therapy Debridement + Toad Brace
* Other: Optimal Medical Therapy - Debridement


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Debridement and standard of care in off-loading on control patients | Other: Optimal Medical Therapy - Debridement<br> <br> |
| Experimental: Toad Brace<br>Debridement and fitting of Toad Brace | Device: Optimal Medical Therapy Debridement + Toad Brace<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline measured wound area | We are taking repeated measures of wound area healing for pedal ulcers over a period of 12 weeks. | Every 3 weeks for a period of 12 weeks |