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

Phase 3

Completed

• Conditions: Diabetes; Diabetic Ulcer
• Interventions: Drug: SBG; Drug: Placebo Comparator

• Registration Number: NCT00804414
• Lead Sponsor: Biotec Pharmacon ASA

Brief 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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-25
• Last Update Posted: 2010-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• Patients with chronic diabetic foot ulcer

Exclusion Criteria

• Insufficient nutritional status, renal function or diabetes control

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SBG	-
2	Placebo Comparator	-

Primary Outcome Measures

Name	Time	Method
Compare the proportion of patients in the two arms who have complete healing of target ulcer	Maximum 12 weeks

Trial Locations

Locations (1)

Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain