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

Phase 3

Completed

• Conditions: Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus
• Interventions: Drug: placebo of rhEGF(recombinant human Epidermal Growth Factor); Drug: rhEGF(recombinant human Epidermal Growth Factor)

• Registration Number: NCT01629199
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-01
• Last Update Posted: 2014-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 176

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo of rhEGF(recombinant human Epidermal Growth Factor)	BID
rhEGF(recombinant human Epidermal Growth Factor)	rhEGF(recombinant human Epidermal Growth Factor)	BID

Primary Outcome Measures

Name	Time	Method
At 12 weeks, wound closure rate of diabetic foot ulcers	12 weeks from the start day of treatment (But, the study can be finished before 12 weeks)

Secondary Outcome Measures

Name	Time	Method
Time to reach complete wound closure	12weeks
average size reduction of diabetic ulcer	12 week

Trial Locations

Locations (1)

College of Medicine, Yonsei University; 🇰🇷 Seoul, Korea, Republic of