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:
Information provided by:
Biotec Pharmacon ASA
ClinicalTrials.gov Identifier:
NCT00804414
First received: December 5, 2008
Last updated: January 25, 2010
Last verified: January 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00804414

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

No publications provided

Responsible Party: Vice President Clinical Development, Biotec Pharmacon ASA
ClinicalTrials.gov Identifier: NCT00804414     History of Changes
Other Study ID Numbers: SBG-1-13
Study First Received: December 5, 2008
Last Updated: January 25, 2010
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Foot Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer

ClinicalTrials.gov processed this record on August 20, 2014