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

This study has been completed.
Information provided by:
Biotec Pharmacon ASA Identifier:
First received: December 5, 2008
Last updated: January 25, 2010
Last verified: January 2010
Evaluation of efficacy and safety of SBG vs placebo in the treatment of chronic diabetic foot ulcers.

Condition Intervention Phase
Diabetes Diabetic Ulcer Drug: SBG Drug: Placebo Comparator Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Biotec Pharmacon ASA:

Primary Outcome Measures:
  • Compare the proportion of patients in the two arms who have complete healing of target ulcer [ Time Frame: Maximum 12 weeks ]

Enrollment: 133
Study Start Date: October 2008
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: SBG
Solution for topical use
Placebo Comparator: 2 Drug: Placebo Comparator
Solutin for topical use

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with chronic diabetic foot ulcer

Exclusion Criteria:

  • Insufficient nutritional status, renal function or diabetes control
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00804414

Universidad Complutense de Madrid
Madrid, Spain, 28040
Sponsors and Collaborators
Biotec Pharmacon ASA
  More Information

Responsible Party: Vice President Clinical Development, Biotec Pharmacon ASA Identifier: NCT00804414     History of Changes
Other Study ID Numbers: SBG-1-13
Study First Received: December 5, 2008
Last Updated: January 25, 2010

Keywords provided by Biotec Pharmacon ASA:
Diabetic ulcer
Chronic ulcer

Additional relevant MeSH terms:
Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer processed this record on September 20, 2017