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Device
Toad Brace for Diabetic Foot Ulcers
N/A
Waitlist Available
Research Sponsored by Toad Medical Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Diabetes Mellitus*
One or more foot ulcers without clinical evidence of osteomyelitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 weeks for a period of 12 weeks
Awards & highlights
Study Summary
This trial is testing whether the TOAD Medical Corporation Brace can heal ulcers on the feet of people with diabetes. The trial will compare the healing rates of people using the brace to those using conventional therapy.
Who is the study for?
This trial is for men and women over 18 with diabetes who have foot ulcers but no bone infection or widespread cancer. They must be able to walk, understand the study, and commit to appointments. People with recent vascular procedures, calf wounds, gangrene, or severe infections cannot join.Check my eligibility
What is being tested?
The trial tests if the Toad Brace helps heal diabetic foot ulcers better than standard care. It involves 74 patients randomly assigned to either use the brace with optimal medical therapy or just receive medical therapy alone over a period of 12 weeks.See study design
What are the potential side effects?
While specific side effects are not listed for this device-based intervention, potential issues might include skin irritation under the brace, discomfort while wearing it, or difficulty in adjusting to its use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with diabetes.
Select...
I have one or more foot ulcers but no bone infection.
Select...
I have a Grade 1A, 1C, 2A, or 2C ulcer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 weeks for a period of 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 weeks for a period of 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline measured wound area
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Toad BraceExperimental Treatment1 Intervention
Debridement and fitting of Toad Brace
Group II: ControlActive Control1 Intervention
Debridement and standard of care in off-loading on control patients
Find a Location
Who is running the clinical trial?
Toad Medical CorporationLead Sponsor
University Hospitals Cleveland Medical CenterOTHER
318 Previous Clinical Trials
340,011 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot commit to the schedule required for this study.I have been diagnosed with diabetes.I am unable to get out of bed or walk by myself.I understand and am willing to follow the study's requirements.Your ankle and toe blood pressure is within a certain range.I have a widespread cancer or a disease that weakens my immune system.I have a bone infection in my foot along with an ulcer.You have a short expected lifespan.I have wounds on my calf or shin that would touch a leg brace.I am over 18 years old.I do not have gangrene or an active infection.I have one or more foot ulcers but no bone infection.I had a procedure to restore blood flow on the same side of my body within the last month.I have a Grade 1A, 1C, 2A, or 2C ulcer.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Toad Brace
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently recruiting participants?
"The information on clinicaltrials.gov reveals that this research endeavour is not actively recruiting patients; the initial posting was December 1st 2013 and last updated January 30th 2014. Despite this, there are 390 other trials currently enrolling participants in various locations worldwide."
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