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NCT00709514

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

Completed Phase 2 Last updated 8 July 2013
What this trial tests

Phase 2 trial testing DCB-WH1 ointment in Chronic Diabetic Foot Ulcer in 41 participants. Completed in 1 March 2012.

Timeline
1 December 2008
Primary endpoint
1 April 2011
1 March 2012

Quick facts

Lead sponsorOneness Biotech Co., Ltd.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment41
Start date1 December 2008
Primary completion1 April 2011
Estimated completion1 March 2012
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Oneness Biotech Co., Ltd. — full company profile →

Who can join

20 and older, any sex, with Chronic Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Growth factors for treating diabetic foot ulcers.
    Martí-Carvajal AJ, Gluud C, Nicola S, Simancas-Racines D, et al · · 2015 · cited 94× · PMID 26509249 · DOI 10.1002/14651858.cd008548.pub2
  2. Plectranthus amboinicus and Centella asiatica Cream for the Treatment of Diabetic Foot Ulcers.
    Kuo YS, Chien HF, Lu W. · · 2012 · cited 26× · PMID 22693530 · DOI 10.1155/2012/418679

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00709514.

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