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

January 25, 2010 updated by: Biotec Pharmacon ASA

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

133

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Universidad Complutense de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with chronic diabetic foot ulcer

Exclusion Criteria:

  • Insufficient nutritional status, renal function or diabetes control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo Comparator
Solutin for topical use
EXPERIMENTAL: 1
Drug: SBG
Solution for topical use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the proportion of patients in the two arms who have complete healing of target ulcer
Time Frame: Maximum 12 weeks
Maximum 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotec Pharmacon ASA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

December 5, 2008

First Submitted That Met QC Criteria

December 5, 2008

First Posted (ESTIMATE)

December 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2010

Last Update Submitted That Met QC Criteria

January 25, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBG-1-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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