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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Collagenase ointment topical application, once daily for 14 days, modified Contact Cast System, applied at days 0,3, and 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagenase ointment | Drug | 250 collagenase units/g |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Kirsner, MD, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami, University of Miami Hospital & Clinics | Miami | Florida | 33136 | United States |
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| Label | URL |
|---|---|
| Wound Research Clinic. University of Miami | View source |
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| ID | Term |
|---|---|
| D016523 | Foot Ulcer |
| D017719 | Diabetic Foot |
| D018409 | Foot Injuries |
| ID | Term |
|---|---|
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
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| ID | Term |
|---|---|
| D017364 | Collagenases |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Modified Contact Cast System | Device | 1 Unit |
|
|
| D012883 |
| Skin Ulcer |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |