Status:

COMPLETED

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

Lead Sponsor:

Biotec Pharmacon ASA

Conditions:

Diabetes

Diabetic Ulcer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • Patients with chronic diabetic foot ulcer

Exclusion

  • Insufficient nutritional status, renal function or diabetes control

Key Trial Info

Start Date :

October 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2009

Estimated Enrollment :

133 Patients enrolled

Trial Details

Trial ID

NCT00804414

Start Date

October 1 2008

End Date

September 1 2009

Last Update

January 26 2010

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Universidad Complutense de Madrid

Madrid, Spain, 28040