EZCast-DFU Study With Portal for Application of Topical Medications

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02131961
Study type	Interventional
Source	University of Miami
Contact
Status	Completed
Phase	Phase 1
Start date	October 2014
Completion date	June 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06154915` - Immune Cells in Diabetic Chronic Foot Ulcers
Completed	`NCT04624516` - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence	N/A
Completed	`NCT02373592` - Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer	N/A
Active, not recruiting	`NCT01903044` - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating	Phase 1/Phase 2
Completed	`NCT02092870` - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds	Phase 2
Completed	`NCT01212120` - The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections	N/A
Completed	`NCT00402727` - Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection	Phase 3
Recruiting	`NCT04085705` - The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)
Completed	`NCT04054804` - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting	`NCT04537676` - Patient Empowerment Study
Completed	`NCT04480801` - The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer	N/A
Recruiting	`NCT04564443` - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot	N/A
Recruiting	`NCT05974592` - The Effect of Nurse-Led Diabetic Foot Self-Management Training Program	N/A
Not yet recruiting	`NCT04630795` - ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.
Not yet recruiting	`NCT05431660` - Diabetic Foot School and Biomechanics	N/A
Completed	`NCT05101473` - Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study	N/A
Completed	`NCT05123157` - Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study
Enrolling by invitation	`NCT05043636` - Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
Completed	`NCT03254095` - Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.
Terminated	`NCT01657318` - Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

EZCast-DFU Study With Portal for Application of Topical Medications — EZCast-DFU

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms