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EZCast-DFU Study With Portal for Application of Topical Medications

NCT02131961 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2015-06-10

No results posted yet for this study

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.

Conditions

  • Foot Ulcer
  • Diabetic Foot

Interventions

DRUG

Collagenase ointment

250 collagenase units/g

DEVICE

Modified Contact Cast System

1 Unit

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Robert S Kirsner, MD, PhD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02131961 on ClinicalTrials.gov