search
Back to results

EZCast-DFU Study With Portal for Application of Topical Medications (EZCast-DFU)

Primary Purpose

Foot Ulcer, Diabetic Foot

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Collagenase ointment
Modified Contact Cast System
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer focused on measuring diabetic foot, foot ulcer, foot wound, plantar ulcer, plantar wound, contact cast, collagenase

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or females between 18 and 80 years of age (inclusive) with diabetes type 1 or type 2
  • Patients must sign an informed consent
  • Diabetic medications must be stable for 4 weeks prior to randomization.
  • Patients with a plantar ulcer
  • Ulcer with an area between ≥ 1 cm2 and ≤ 10 cm2
  • Patients must agree to comply with at least daily dressing changes and off-loading according to protocol requirements;
  • Ulcer at least 6 weeks but not more than 12 months old
  • Diabetic patients who use a medication to lower blood glucose levels who, in the opinion of the investigator, are considered "controlled" diabetics
  • Adequate perfusion of the foot with the ulcer
  • No prior use of Santyl on the target ulcer or treatment within one month with other bioactive therapies

Exclusion Criteria:

  • Patients with more than two ulcers on the same foot
  • Patients with ulcer requiring off-loading that cannot be effectively off-loaded
  • Patients with ulcer above the plantar foot;
  • Patient non-compliance with protocol-required off-loading and dressing change
  • Patients with infected ulcers
  • Patients with severe edema (defined as inability to fit leg into off-loading device);
  • Patients with a gangrenous or ischemic toe that may need to be amputated in the opinion of the investigator;
  • Patients with Buerger's disease, vasculitis or connective tissue disease;
  • Ankle brachial index >1.2 (ABI >1.2 must be confirmed by another method such as Transcutaneous partial pressure oxygen (TcPO2) > 40 mm Hg at the ankle or Toe pressure of > 40mm Hg or Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) or Skin Perfusion Pressure (SPP) > 40 mm Hg);
  • Patients with claudication
  • Body mass index (BMI) > 40 kg/m2
  • There is active Charcot's joint by clinical or radiographic criteria.
  • Unable or unwilling to provide informed consent.
  • Known HIV infection and/or AIDS based on participant self-report.
  • Patients with contraindication to contact casting (ie. peripheral vascular disease, Infection)

Sites / Locations

  • University of Miami, University of Miami Hospital & Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study arm

Arm Description

Collagenase ointment topical application, once daily for 14 days, modified Contact Cast System, applied at days 0,3, and 7.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 2, 2014
Last Updated
June 9, 2015
Sponsor
University of Miami
search

1. Study Identification

Unique Protocol Identification Number
NCT02131961
Brief Title
EZCast-DFU Study With Portal for Application of Topical Medications
Acronym
EZCast-DFU
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic Foot
Keywords
diabetic foot, foot ulcer, foot wound, plantar ulcer, plantar wound, contact cast, collagenase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Arm Description
Collagenase ointment topical application, once daily for 14 days, modified Contact Cast System, applied at days 0,3, and 7.
Intervention Type
Drug
Intervention Name(s)
Collagenase ointment
Other Intervention Name(s)
Santyl
Intervention Description
250 collagenase units/g
Intervention Type
Device
Intervention Name(s)
Modified Contact Cast System
Other Intervention Name(s)
Modified TCC-EZ(R) Total Contact Cast System
Intervention Description
1 Unit
Primary Outcome Measure Information:
Title
Proportion of contact cast systems intact by day 14
Description
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
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females between 18 and 80 years of age (inclusive) with diabetes type 1 or type 2 Patients must sign an informed consent Diabetic medications must be stable for 4 weeks prior to randomization. Patients with a plantar ulcer Ulcer with an area between ≥ 1 cm2 and ≤ 10 cm2 Patients must agree to comply with at least daily dressing changes and off-loading according to protocol requirements; Ulcer at least 6 weeks but not more than 12 months old Diabetic patients who use a medication to lower blood glucose levels who, in the opinion of the investigator, are considered "controlled" diabetics Adequate perfusion of the foot with the ulcer No prior use of Santyl on the target ulcer or treatment within one month with other bioactive therapies Exclusion Criteria: Patients with more than two ulcers on the same foot Patients with ulcer requiring off-loading that cannot be effectively off-loaded Patients with ulcer above the plantar foot; Patient non-compliance with protocol-required off-loading and dressing change Patients with infected ulcers Patients with severe edema (defined as inability to fit leg into off-loading device); Patients with a gangrenous or ischemic toe that may need to be amputated in the opinion of the investigator; Patients with Buerger's disease, vasculitis or connective tissue disease; Ankle brachial index >1.2 (ABI >1.2 must be confirmed by another method such as Transcutaneous partial pressure oxygen (TcPO2) > 40 mm Hg at the ankle or Toe pressure of > 40mm Hg or Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) or Skin Perfusion Pressure (SPP) > 40 mm Hg); Patients with claudication Body mass index (BMI) > 40 kg/m2 There is active Charcot's joint by clinical or radiographic criteria. Unable or unwilling to provide informed consent. Known HIV infection and/or AIDS based on participant self-report. Patients with contraindication to contact casting (ie. peripheral vascular disease, Infection)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Kirsner, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami, University of Miami Hospital & Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Links:
URL
http://dermatology.med.miami.edu/research/cutting-edge-wound-research
Description
Wound Research Clinic. University of Miami

Learn more about this trial

EZCast-DFU Study With Portal for Application of Topical Medications

We'll reach out to this number within 24 hrs