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

NCT ID: NCT00804414

Last Updated: 2010-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Diabetic Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

SBG

Intervention Type DRUG

Solution for topical use

2

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Solutin for topical use

Interventions

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SBG

Solution for topical use

Intervention Type DRUG

Placebo Comparator

Solutin for topical use

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic diabetic foot ulcer

Exclusion Criteria

* Insufficient nutritional status, renal function or diabetes control
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotec Pharmacon ASA

INDUSTRY

Sponsor Role lead

Responsible Party

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Biotec Pharmacon ASA

Locations

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Universidad Complutense de Madrid

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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SBG-1-13

Identifier Type: -

Identifier Source: org_study_id

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