Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus
Conditions
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.
Interventions
DRUGrhEGF(recombinant human Epidermal Growth Factor)
DRUGplacebo of rhEGF(recombinant human Epidermal Growth Factor)
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Time to reach complete wound closure | 12weeks |
| average size reduction of diabetic ulcer | 12 week |
Countries
South Korea
Outcome results
None listed