NCT00804414

Efficacy and Safety Study of Soluble Beta-1,3/1,6-glucan (SBG) Versus Placebo in Chronic Diabetic Foot Ulcers

A Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Soluble Beta-1,3/1,6-glucan (SBG) in Chronic Foot Ulcers in Patients With Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Biotec Pharmacon ASA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of efficacy and safety of SBG vs placebo in the treatment of chronic diabetic foot ulcers.

Detailed description

The objective of this study is to evaluate efficacy and safety of soluble beta-1,3/1,6-glucan (SBG) on chronic diabetic foot ulcers.

Conditions

• Diabetes
• Diabetic Ulcer

Interventions

Type	Name	Description
DRUG	SBG	Solution for topical use
DRUG	Placebo Comparator	Solutin for topical use

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-08-01
• Completion: 2009-09-01
• First posted: 2008-12-08
• Last updated: 2010-01-26

Locations

1 site across 1 country: Spain