Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 25, 2012
August 1, 2014
October 2010
September 2012   (final data collection date for primary outcome measure)
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 ]
At 12 weeks, wound closure rate of diabetic foot ulcers
Complete list of historical versions of study NCT01629199 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time to reach complete wound closure
  • At 12 weeks, average size ruduction of diabetic ulcer
  • At 12 weeks, average size rudction ratio of diabetic ulcer
  • The time to ruduce ulcer size, 1㎠
Not Provided
Not Provided
 
Efficacy and Safety of rhEGF in Diabetic Foot Ulcer Patients With Uncontrolled Diabetic Mellitus
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus
  • Drug: rhEGF(recombinant human Epidermal Growth Factor)
  • Drug: placebo of rhEGF(recombinant human Epidermal Growth Factor)
  • Experimental: rhEGF(recombinant human Epidermal Growth Factor)
    BID
    Intervention: Drug: rhEGF(recombinant human Epidermal Growth Factor)
  • Placebo Comparator: placebo
    BID
    Intervention: Drug: placebo of rhEGF(recombinant human Epidermal Growth Factor)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
September 2012
September 2012   (final data collection date for primary outcome measure)
Not Provided
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01629199
DW-EGF011P
Not Provided
Daewoong Pharmaceutical Co. LTD.
Daewoong Pharmaceutical Co. LTD.
Not Provided
Not Provided
Daewoong Pharmaceutical Co. LTD.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP