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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804414
• Other study ID #: SBG-1-13
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2008
• Last updated: January 25, 2010
• Start date: October 2008
• Est. completion date: September 2009

Study information

• Verified date: January 2010
• Source: Biotec Pharmacon ASA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with chronic diabetic foot ulcer

Exclusion Criteria:

• Insufficient nutritional status, renal function or diabetes control

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetic Ulcer
• Ulcer

Intervention

Drug:
• SBG
Solution for topical use
• Placebo Comparator
Solutin for topical use

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Biotec Pharmacon ASA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the proportion of patients in the two arms who have complete healing of target ulcer		Maximum 12 weeks	No