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

January 30, 2014 updated by: Toad Medical Corporation
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • UH Hospitals of Cleveland d/b/a University Hospitals Case Medical
        • Principal Investigator:
          • Vikram S Kashyap, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every 3 weeks for a period of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toad Medical Corporation

Collaborators

University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

February 3, 2014

Study Record Updates

Last Update Posted (Estimate)

February 3, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Toad_Brace_07-13-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Foot

Clinical Trials on Optimal Medical Therapy - Debridement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe