Recruiting

Toad Brace

Sponsor:

Toad Medical Corporation

Code:

NCT02052817

Conditions

Diabetic Foot

Pedal Ulcers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Optimal Medical Therapy Debridement + Toad Brace

Optimal Medical Therapy - Debridement

Study Details

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.

Conditions

Diabetic Foot

Pedal Ulcers

Study ID

NCT02052817

Start date

Dec, 2013

Status verified date

Jan, 2014

Primary completion date

May, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

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

experimental: Toad Brace

Debridement and fitting of Toad Brace

Interventions

Optimal Medical Therapy Debridement + Toad Brace

Optimal Medical Therapy - Debridement

Primary outcome measure

  • Change from baseline measured wound area [ Time Frame: Every 3 weeks for a period of 12 weeks ]

Central Contacts and Locations

Central contacts

Lori Hammer, RN

216-983-4719lori.hammer@uhhospitals.org

Locations

UH Hospitals of Cleveland d/b/a University Hospitals Case Medical

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Vikram S Kashyap, MD

More Information

Sponsor

Toad Medical Corporation

Last update posted

Feb 3, 2014

Last verified

Jan, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Toad Medical Corporation on 2014-02-03.