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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01629199
First received: June 25, 2012
Last updated: July 12, 2012
Last verified: July 2012
  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

Secondary Outcome Measures:
  • Time to reach complete wound closure
  • At 12 weeks, average size reduction of diabetic ulcer

Estimated Enrollment: 176
Study Start Date: October 2010
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGF
rhEGF(recombinant human Epidermal Growth Factor)
Drug: rhEGF(recombinant human Epidermal Growth Factor)
Placebo Comparator: placebo 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
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: July 12, 2012
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 April 22, 2014