Back to resultsEfficacy and Safety Study of Soluble Beta-1,3/1,6-glucan (SBG) Versus Placebo in Chronic Diabetic Foot Ulcers
Primary Purpose
Diabetes, Diabetic Ulcer
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
SBG
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Diabetes, Diabetic ulcer, Chronic ulcer, SBG
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic diabetic foot ulcer
Exclusion Criteria:
- Insufficient nutritional status, renal function or diabetes control
Sites / Locations
- Universidad Complutense de Madrid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Compare the proportion of patients in the two arms who have complete healing of target ulcer
Secondary Outcome Measures
Full Information
NCT ID
NCT00804414
First Posted
December 5, 2008
Last Updated
January 25, 2010
Sponsor
Biotec Pharmacon ASA
1. Study Identification
Unique Protocol Identification Number
NCT00804414
Brief Title
Efficacy and Safety Study of Soluble Beta-1,3/1,6-glucan (SBG) Versus Placebo in Chronic Diabetic Foot Ulcers
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 Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biotec Pharmacon ASA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetic Ulcer
Keywords
Diabetes, Diabetic ulcer, Chronic ulcer, SBG
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SBG
Intervention Description
Solution for topical use
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Solutin for topical use
Primary Outcome Measure Information:
Title
Compare the proportion of patients in the two arms who have complete healing of target ulcer
Time Frame
Maximum 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with chronic diabetic foot ulcer
Exclusion Criteria:
Insufficient nutritional status, renal function or diabetes control
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Soluble Beta-1,3/1,6-glucan (SBG) Versus Placebo in Chronic Diabetic Foot Ulcers
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