Soluble Beta-glucan (SBG) as Treatment for Diabetic Foot Ulcers

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

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study is to determine whether the application of soluble beta-glucan (SBG) onto diabetic foot ulcers improves the healing of the ulcers.

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Detailed Description

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Conditions

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Chronic Diabetic Foot Ulcers

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

SBG

Group Type EXPERIMENTAL

Soluble beta-glucan (SBG)

Intervention Type DRUG

Topical application of SBG to the wound, at least twice a week until complete healing or for 8 maximum weeks

2

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DRUG

Topical application of placebo to wound, at least twice a week until compleate healing or for maximum 8 weeks.

Interventions

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Soluble beta-glucan (SBG)

Topical application of SBG to the wound, at least twice a week until complete healing or for 8 maximum weeks

Intervention Type DRUG

Placebo comparator

Topical application of placebo to wound, at least twice a week until compleate healing or for maximum 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 1 or Type 2 diabetes mellitus
* Age ≥ 18 years
* One or more full-thickness ulcers at or below the level of the malleoli, which do not extend to tendon, joint, or bone
* The ulcer (or index ulcer, if appropriate) must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years
* Ankle:brachial pressure index (ABPI) \>0.7, or the presence of two palpable pulses on the affected foot
* Ulcer area \>25 mm2 but \<500 mm2
* Written informed consent

Exclusion Criteria

* Pregnancy, lactation or absence of adequate contraception for women with child bearing capacity
* ABPI \< 0.7
* Serum albumin \< 2.0 g/dL
* Gangrene on any part of the foot with the study ulcer
* Presence of signs of clinically significant foot infection on Day 0
* Chronic renal failure with calculated GFR \<30 ml/min
* Surgical procedure (other than debridement) on the foot with the study ulcer in the 28 days prior to Day 0
* HbA1c 12% or more
* Current alcohol or drug abuse
* Participation in other studies in the preceding 28 days
* An ulcer on a foot affected by acute Charcot osteoarthropathy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No