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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02052817
• Other study ID #: Toad_Brace_07-13-11
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2014
• Last updated: January 30, 2014
• Start date: December 2013

Study information

• Verified date: January 2014
• Source: Toad Medical Corporation
• Contact: Lori Hammer, RN
• Phone: 216-983-4719
• Email: lori.hammer[@]uhhospitals.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Pedal Ulcers
• Ulcer

Intervention

Device:
• Optimal Medical Therapy Debridement + Toad Brace

Other:
• Optimal Medical Therapy - Debridement

Locations

Country	Name	City	State
United States	UH Hospitals of Cleveland d/b/a University Hospitals Case Medical	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Toad Medical Corporation	University Hospital Case Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No