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Completed

NCT Number: NCT00804414

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

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

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetic Ulcer Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universidad Complutense de Madrid

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic diabetic foot ulcer

Exclusion criteria

  • Insufficient nutritional status, renal function or diabetes control

Treatment and study plan

SBG

Drug

Solution for topical use

placebo comparator

Drug

Solutin for topical use

Primary outcomes

  1. Compare the proportion of patients in the two arms who have complete healing of target ulcer

    Time frame: Maximum 12 weeks

Sponsors and collaborators

Lead sponsor

Biotec Pharmacon ASA

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 8, 2008
Registry last updated
Jan 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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