NCT02078128

Brief Summary

The purpose of this study is to determine the effect of β-glucans on wound healing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

1 month

First QC Date

September 17, 2012

Last Update Submit

March 3, 2014

Conditions

Burns

Keywords

burn, wound healing, skin graft

Outcome Measures

Primary Outcomes (1)

  • Wound healing percentage

    record data by taking picture

    every Monday and Thuresday for the duration of hospital stay, an expected average of 3 weeks

Study Arms (2)

oral beta-glucans

EXPERIMENTAL

Daily give kg per day to 30 mg of β-glucan (30mg/kg/day), taking to the wound healed.

Drug: oral sugar powder

oral sugar powder

PLACEBO COMPARATOR

control group, daily give and the glucose powder 30 mg per kilogram of body weight (30mg/kg/day) a day, taking to the wound healed.

Dietary Supplement: oral beta-glucans

Interventions

oral beta-glucansDIETARY_SUPPLEMENT

30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.

Also known as: D-glucose polysaccharides
oral sugar powder
oral sugar powderDRUG

30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.

Also known as: placebo, sugar, glucose
oral beta-glucans

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Total burn area under 20%, two to three degree burn and need skin-grafting.
  • Subjects don't have other diseases.
  • Subjects' age between 20 to 60.

You may not qualify if:

  • Subjects with hypersensitivity.
  • Subjects with Autoimmune disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Burns

Interventions

beta-GlucansSugarsGlucose

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydratesHexosesMonosaccharides

Study Officials

  • Eng Kean Yeong

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2012

First Posted

March 5, 2014

Study Start

July 1, 2011

Primary Completion

August 1, 2011

Study Completion

February 1, 2013

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

TW(1)