Back to resultsEfficacy and Safety of rhEGF in Diabetic Foot Ulcer Patients With Uncontrolled Diabetic Mellitus
Primary Purpose
Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
rhEGF(recombinant human Epidermal Growth Factor)
placebo of rhEGF(recombinant human Epidermal Growth Factor)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus
Eligibility Criteria
Sites / Locations
- College of Medicine, Yonsei University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
rhEGF(recombinant human Epidermal Growth Factor)
placebo
Arm Description
BID
BID
Outcomes
Primary Outcome Measures
At 12 weeks, wound closure rate of diabetic foot ulcers
Secondary Outcome Measures
Time to reach complete wound closure
average size reduction of diabetic ulcer
Full Information
NCT ID
NCT01629199
First Posted
June 25, 2012
Last Updated
August 1, 2014
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT01629199
Brief Title
Efficacy and Safety of rhEGF in Diabetic Foot Ulcer Patients With Uncontrolled Diabetic Mellitus
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rhEGF(recombinant human Epidermal Growth Factor)
Arm Type
Experimental
Arm Description
BID
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
BID
Intervention Type
Drug
Intervention Name(s)
rhEGF(recombinant human Epidermal Growth Factor)
Intervention Type
Drug
Intervention Name(s)
placebo of rhEGF(recombinant human Epidermal Growth Factor)
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Time to reach complete wound closure
Time Frame
12weeks
Title
average size reduction of diabetic ulcer
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Facility Information:
Facility Name
College of Medicine, Yonsei University
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of rhEGF in Diabetic Foot Ulcer Patients With Uncontrolled Diabetic Mellitus
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