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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01629199
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus Drug: rhEGF(recombinant human Epidermal Growth Factor) Drug: placebo of rhEGF(recombinant human Epidermal Growth Factor) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2010
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Urogastrone
U.S. FDA Resources

Arms and Interventions

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)


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. Time to reach complete wound closure [ Time Frame: 12weeks ]
  2. average size reduction of diabetic ulcer [ Time Frame: 12 week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629199


Locations
Korea, Republic of
College of Medicine, Yonsei University
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
More Information

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01629199     History of Changes
Other Study ID Numbers: DW-EGF011P
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Diabetic Foot
Foot Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies
Foot Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action