Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus Clinical Trial
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.
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.
| Status | Completed |
| Enrollment | 176 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | College of Medicine, Yonsei University | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Daewoong Pharmaceutical Co. LTD. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No | |
| Secondary | Time to reach complete wound closure | 12weeks | No | |
| Secondary | average size reduction of diabetic ulcer | 12 week | No |