EZCast-DFU Study With Portal for Application of Topical Medications (EZCast-DFU)
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|ClinicalTrials.gov Identifier: NCT02131961|
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : June 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Foot Ulcer Diabetic Foot||Drug: Collagenase ointment Device: Modified Contact Cast System||Phase 1|
The accepted care of a diabetic foot ulcer includes cleaning of the wound of the dead and dying tissue around the wound, daily wound care, good nutrition, and adequate relief of pressure. Pressure reduction, commonly known as "off-loading," is most often achieved by having the patient wear an "off-loading boot". However, using a cast similar to the cast used to treat broken bones will result in less activity and better wound healing. The cast is considered the best method for off-loading the foot but is not used as often as other methods because the cast covers the foot ulcer and it does not allow you to perform daily cleaning and examination.
This study will apply a Total Contact Cast (TCC)System and leave an opening where the ulcer can be treated on a daily basis by the investigators. Patients will be asked to apply an ointment called Santyl ® to their ulcer on a daily basis. Santyl ® ointment is an FDA approved drug that is routinely used on foot ulcers. The Santyl ® ointment cleans wounds to promote a better environment for wounds to heal. It helps remove nonliving tissue without harming the new healing tissue.
Trial will last 14 days and it will consist of 4 visits. In the first visits, patients' wounds will be cleaned from dead and dying tissue (debridement) and the first modified contact cast will be applied. Patients will be provided Santyl to apply daily with reapplication of foam dressing. Patients will return at day 3, and then weekly for 2 weeks for standard evaluation and debridement and wound measurements and at day 3, and week 1 visit for reapplication of the modified contact cast.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Feasibility of Using a Modified Cast Walker With a Portal for Application of Topical Medications in Diabetic Foot Ulcers|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Study arm
Collagenase ointment topical application, once daily for 14 days, modified Contact Cast System, applied at days 0,3, and 7.
Drug: Collagenase ointment
250 collagenase units/g
Other Name: Santyl
Device: Modified Contact Cast System
Other Name: Modified TCC-EZ(R) Total Contact Cast System
- Proportion of contact cast systems intact by day 14 [ Time Frame: 14 days ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131961
|United States, Florida|
|University of Miami, University of Miami Hospital & Clinics|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Robert S Kirsner, MD, PhD||University of Miami|