Diabetic FootNCT02052817
Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing
A study testing Optimal Medical Therapy Debridement + Toad Brace and Optimal Medical Therapy - Debridement in people with Diabetic Foot and Pedal Ulcers, run by Toad Medical Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Pedal Ulcers
- What is being tested?
- Optimal Medical Therapy Debridement + Toad Brace and Optimal Medical Therapy - Debridement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Wide spread malignancy or systemically immunocompromising disease
- Ipsilateral revascularization procedure within the last 30 days.
- Unreliable, unwilling or unable to comprehend informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UH Hospitals of Cleveland d/b/a University Hospitals Case Medical
Cleveland, Ohio, 44106
Vikram S Kashyap, MD
About this study
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
- Being tested
- Optimal Medical Therapy Debridement + Toad Brace, Optimal Medical Therapy - Debridement
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal Medical Therapy Debridement + Toad BraceDevice
Optimal Medical Therapy - DebridementOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Debridement and standard of care in off-loading on control patients Receives: Other: Optimal Medical Therapy - Debridement |
| Toad Brace | Experimental | Debridement and fitting of Toad Brace Receives: Device: Optimal Medical Therapy Debridement + Toad Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline measured wound area
We are taking repeated measures of wound area healing for pedal ulcers over a period of 12 weeks.
Measured: Every 3 weeks for a period of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toad Medical Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052817
- Sponsor's protocol ID
- Toad_Brace_07-13-11
- Status last verified
- Jan 2014
- First submitted
- 20 Jan 2014
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing
- ClinicalTrials.gov ID
- NCT02052817
- Acronym / sponsor ID
- Toad_Brace_07-13-11
- Conditions
- Diabetic Foot, Pedal Ulcers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Toad Medical CorporationUniversity, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Study start
- Dec 2013
- Primary completion
- May 2014 (estimated)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Optimal Medical Therapy - DebridementDebridement and standard of care in off-loading on control patients |
| Toad Brace | Experimental | Device: Optimal Medical Therapy Debridement + Toad BraceDebridement and fitting of Toad Brace |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimal Medical Therapy Debridement + Toad Brace | Device | Toad Brace |
| Optimal Medical Therapy - Debridement | Other | Control |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal Medical Therapy Debridement + Toad Brace and Optimal Medical Therapy - Debridement in people with Diabetic Foot and Pedal Ulcers, run by Toad Medical Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lori Hammer, RN (216-983-4719, lori.hammer@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline measured wound area (time frame: Every 3 weeks for a period of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.