Clinical Trial: Oral BBR-012 in the Treatment of Diabetic Foot Ulcers, Proof of Concept Study

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomised, Double-Blind, Repeat-Dose, Placebo-Controlled Phase IIa Proof of Concept Study to Investigate the Safety and Efficacy of Oral BBR-012 in Combination With Standard Medical Care in Diabeti

Brief Summary: The aim of this Clinical Proof of Principle study is to evaluate the effect of BBR-012 on the healing of complicated diabetic foot ulcers.

Detailed Summary:
Sponsor: Bridge BioResearch Ltd.

Current Primary Outcome: Rate of healing of diabetic foot ulcers (% reduction in area from baseline) [ Time Frame: 4, 8 and 12 weeks ]

Original Primary Outcome: Rate of healing of diabetic foot ulcers (% reduction in area) [ Time Frame: 4, 8 and 12 weeks ]

Current Secondary Outcome:

  • Rate of healing (change from baseline) as assessed by various scoring criteria: IDSA, modified ASEPSIS score, TEXAS Diabetic wound score, composite severity score and global clinical assessment [ Time Frame: week 1, 2, 3, 4, 6, 8, 10, 12 and 13-14(follow up) ]
  • Effect of BBR-012 on the level of ischemia (change from baseline as measured by tcpO2) [ Time Frame: 4, 8 and 12 weeks ]
  • Effect of BBR-012 on microbiological outcome (presence of pathogens and outcome as compared to baseline) [ Time Frame: week 1, 2, 3, 4, 6, 8, 10, 12 and 13-14(follow up) ]
  • Safety and tolerability of BBR-012 as assessed by reported adverse events and safety laboratory parameters [ Time Frame: from baseline visit to week 14 ]


Original Secondary Outcome:

  • Rate of healing as assessed by various scoring criteria: IDSA, modified ASEPSIS score, TEXAS Diabetic wound score, composite severity score and global clinical assessment [ Time Frame: week 1, 2, 3, 4, 6, 8, 10, 12 and 13-14(follow up) ]
  • Effect of BBR-012 on the level of ischemia (as measured by tcpO2) [ Time Frame: 4, 8 and 12 weeks ]
  • Effect of BBR-012 on microbiological outcome (presence of pathogens and outcome) [ Time Frame: week 1, 2, 3, 4, 6, 8, 10, 12 and 13-14(follow up) ]
  • Safety and tolerability of BBR-012 as assessed by reported adverse events and safety laboratory parameters [ Time Frame: from baseline visit to week 14 ]


Information By: Bridge BioResearch Ltd.

Dates:
Date Received: April 12, 2011
Date Started: July 2011
Date Completion: August 2012
Last Updated: December 22, 2011
Last Verified: December 2011