NCT00709514

Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers

A Phase II, Double-blind, Placebo-controlled Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Oneness Biotech Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this Phase 2 study is to evaluate the efficacy of DCB-WH1 ointment in wound closure as compared to vehicle control when applied topically to chronic diabetic foot ulcers for 12 weeks. The secondary objective of this study is to collect safety information of DCB-WH1 ointment. This is a randomized, double-blind, parallel group, vehicle-controlled, multi-center study of DCB-WH1 ointment applied topically to grade 1 foot ulcers (according to Wagner grading system) in 50 subjects with diabetes mellitus.

Conditions

• Chronic Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	DCB-WH1 ointment	DCB-WH1 ointment (1.25%), topically applied twice daily
DRUG	Placebo	Placebo

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-04-01
• Completion: 2012-03-01
• First posted: 2008-07-03
• Last updated: 2013-07-09

Locations

1 site across 1 country: Taiwan