Completed

NCT Number: NCT01629199

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

Completed

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Key information

Conditions

Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

College of Medicine, Yonsei University

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Treatment and study plan

rhEGF(recombinant human Epidermal Growth Factor)

Drug

placebo of rhEGF(recombinant human Epidermal Growth Factor)

Drug

Primary outcomes

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 outcomes

Time to reach complete wound closure

Time frame: 12weeks
average size reduction of diabetic ulcer

Time frame: 12 week

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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.

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jun 27, 2012
Registry last updated: Aug 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.