Efficacy and Safety of rhEGF in Diabetic Foot Ulcer Patients With Uncontrolled Diabetic Mellitus

August 1, 2014 updated by: Daewoong Pharmaceutical Co. LTD.

The Clinical Trial for Evaluation of Efficacy and Safety of rhEGF(Recombinant Human Epidermal Growth Factor) in Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus.

The purpose of this clinical trial is to evaluate the safety and efficacy of rhEGF (recombinant human Epidermal Growth Factor) in diabetic foot ulcer patients with uncontrolled diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rhEGF(recombinant human Epidermal Growth Factor)
BID
Drug: rhEGF(recombinant human Epidermal Growth Factor)
Placebo Comparator: placebo
BID
Drug: placebo of rhEGF(recombinant human Epidermal Growth Factor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
At 12 weeks, wound closure rate of diabetic foot ulcers
Time Frame: 12 weeks from the start day of treatment (But, the study can be finished before 12 weeks)
12 weeks from the start day of treatment (But, the study can be finished before 12 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to reach complete wound closure
Time Frame: 12weeks
12weeks
average size reduction of diabetic ulcer
Time Frame: 12 week
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (Estimate)

June 27, 2012

Study Record Updates

Last Update Posted (Estimate)

August 4, 2014

Last Update Submitted That Met QC Criteria

August 1, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW-EGF011P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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