Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing
NCT ID: NCT02052817
Last Updated: 2014-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
74 participants
INTERVENTIONAL
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
Debridement and standard of care in off-loading on control patients
Optimal Medical Therapy - Debridement
Toad Brace
Debridement and fitting of Toad Brace
Optimal Medical Therapy Debridement + Toad Brace
Interventions
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Optimal Medical Therapy Debridement + Toad Brace
Optimal Medical Therapy - Debridement
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Toad Medical Corporation
OTHER
Responsible Party
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Locations
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UH Hospitals of Cleveland d/b/a University Hospitals Case Medical
Cleveland, Ohio, United States
Countries
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Central Contacts
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Other Identifiers
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Toad_Brace_07-13-11
Identifier Type: -
Identifier Source: org_study_id
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