EZCast-DFU
A Study to Evaluate the Feasibility of Using a Modified Cast Walker With a Portal for Application of Topical Medications in Diabetic Foot Ulcers
Sponsor study identifier
interventional
4
1 country
1
Study Start
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)This study is designed to evaluate the ability to modify a contact cast system so that topical medications can be applied daily to an underlying wound in patients with diabetic plantar ulcers. The modification of the cast will be done by making an opening where the wound is located in the contact cast system. A contact cast system is a device that will reduce the pressure in the area where the wound is located.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2, 2014
Actual (reported)May 6, 2014
Actual (reported)October 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 2015
Actual (reported)June 2015
Actual (reported)Proportion of contact cast systems intact by day 14
Proportion of contact cast systems in whom the investigator assesses as intact (not damaged, or broken by the creation of the window). Intact: Contact cast systems where the window creation did not create unintended fissures or these fissures were less than 1cm length and they originate from the window opening. Damaged: Contact cast systems where window creation creates one or more fissure between 1-3cm of length and these fissures originate from the window opening. Broken: Contact cast systems where window creation creates one or more fissures of length more than 3 cm, or any fissure that did not originate from the site of the window opening
14 days
Collagenase ointment topical application, once daily for 14 days, modified Contact Cast System, applied at days 0,3, and 7.
250 collagenase units/g
1 Unit
University of Miami, University of Miami Hospital & Clinics
Miami, Florida, 33136, United States
Robert S Kirsner, MD, PhD
University of Miami
4 participants (actual enrollment reported by the registry).
First Submitted
May 2, 2014
First Posted
May 6, 2014
Study Start
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
A Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers
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Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)Last Updated
June 10, 2015
Record last verified: 2015-06
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Source: ClinicalTrials.gov.
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