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

Primary Purpose

Chronic Diabetic Foot Ulcers

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Soluble beta-glucan (SBG)
Placebo comparator
Sponsored by
Biotec Pharmacon ASA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Diabetic Foot Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Belfast City Hospital
  • Royal Blackburn Hospital
  • Royal Bournemouth Hospital
  • Southmead Hospital
  • NHS Greater Glasgow and Clyde Victoria
  • Leeds General Infirmary
  • Leicester General Hospital
  • North Manchester Hospital
  • Newcastle General Hospital
  • Northampton General Hospital
  • Nottingham City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

SBG

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 29, 2008
Last Updated
January 25, 2010
Sponsor
Biotec Pharmacon ASA
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1. Study Identification

Unique Protocol Identification Number
NCT00632008
Brief Title
Soluble Beta-glucan (SBG) as Treatment for Diabetic Foot Ulcers
Official Title
A Randomised, Double-blind, Placebo-controlled Study to Determine the Efficacy of Soluble Beta-1,3/1,6-glucan in Chronic Foot Ulcers in Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biotec Pharmacon ASA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diabetic Foot Ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
SBG
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Soluble beta-glucan (SBG)
Intervention Description
Topical application of SBG to the wound, at least twice a week until complete healing or for 8 maximum weeks
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
Topical application of placebo to wound, at least twice a week until compleate healing or for maximum 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Jeffcoate, MD, PhD
Organizational Affiliation
Nottingham City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Royal Blackburn Hospital
City
Blackburn
ZIP/Postal Code
BB2 3LR
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde Victoria
City
Glasgow
ZIP/Postal Code
G42 9TY
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Leicester General Hospital
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
North Manchester Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Newcastle General Hospital
City
Newcastle
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Northampton General Hospital
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

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

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