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

NCT00709514 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2013-07-09

No results posted yet for this study

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

DRUG

DCB-WH1 ointment

DCB-WH1 ointment (1.25%), topically applied twice daily

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Oneness Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Low-Tong Ho, MD · Taipei Veterans General Hospital Taipei

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-04-30
Completion
2012-03-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00709514 on ClinicalTrials.gov