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

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ClinicalTrials.gov Identifier: NCT00804414
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : January 26, 2010
Sponsor:
Information provided by:
Biotec Pharmacon ASA

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

Condition or disease Intervention/treatment Phase
Diabetes Diabetic Ulcer Drug: SBG Drug: Placebo Comparator Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: SBG
Solution for topical use

Placebo Comparator: 2 Drug: Placebo Comparator
Solutin for topical use




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Vice President Clinical Development, Biotec Pharmacon ASA
ClinicalTrials.gov Identifier: NCT00804414     History of Changes
Other Study ID Numbers: SBG-1-13
First Posted: December 8, 2008    Key Record Dates
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