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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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01629199
Enrollment
176
Registered
2012-06-27
Start date
2010-10-31
Completion date
2012-09-30
Last updated
2014-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus

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.
Lead SponsorINDUSTRY

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

MeasureTime frame
At 12 weeks, wound closure rate of diabetic foot ulcers12 weeks from the start day of treatment (But, the study can be finished before 12 weeks)

Secondary

MeasureTime frame
Time to reach complete wound closure12weeks
average size reduction of diabetic ulcer12 week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026