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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01629199
First received: June 25, 2012
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to reach complete wound closure [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
  • average size reduction of diabetic ulcer [ Time Frame: 12 week ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: October 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629199

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

No publications provided

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01629199     History of Changes
Other Study ID Numbers: DW-EGF011P
Study First Received: June 25, 2012
Last Updated: August 1, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on September 14, 2014