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

Toad Medical

Status: Unknown

Conditions: Diabetic Foot; Pedal Ulcers

Treatments: Device: Optimal Medical Therapy Debridement + Toad Brace; Other: Optimal Medical Therapy - Debridement

Study type: Interventional

Funder types: Other

Identifiers

NCT02052817

Toad_Brace_07-13-11

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Control

Active Comparator group

Description:

Debridement and standard of care in off-loading on control patients

Treatment:

Other: Optimal Medical Therapy - Debridement

Toad Brace

Experimental group

Description:

Debridement and fitting of Toad Brace

Treatment:

Device: Optimal Medical Therapy Debridement + Toad Brace