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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus

Treatments: Drug: rhEGF(recombinant human Epidermal Growth Factor); Drug: placebo of rhEGF(recombinant human Epidermal Growth Factor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01629199

DW-EGF011P

Details and patient eligibility

About

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.

Enrollment: 176 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

176 participants in 2 patient groups, including a placebo group

rhEGF(recombinant human Epidermal Growth Factor)

Experimental group

Description:

BID

Treatment:

Drug: rhEGF(recombinant human Epidermal Growth Factor)

placebo

Placebo Comparator group

Description:

BID

Treatment:

Drug: placebo of rhEGF(recombinant human Epidermal Growth Factor)