We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00804414
First Posted: December 8, 2008
Last Update Posted: January 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biotec Pharmacon ASA
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients with chronic diabetic foot ulcer

Exclusion Criteria:

  • Insufficient nutritional status, renal function or diabetes control
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804414


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

Responsible Party: Vice President Clinical Development, Biotec Pharmacon ASA
ClinicalTrials.gov Identifier: NCT00804414     History of Changes
Other Study ID Numbers: SBG-1-13
First Submitted: December 5, 2008
First Posted: December 8, 2008
Last Update Posted: January 26, 2010
Last Verified: January 2010

Keywords provided by Biotec Pharmacon ASA:
Diabetes
Diabetic ulcer
Chronic ulcer
SBG

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer