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

NCT00632008 | Completed Phase 3

• 1 other identifier: SBG-1-12
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 11

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.

Conditions

Chronic Diabetic Foot Ulcers

Study Arms (2)

1

EXPERIMENTAL

SBG

Drug: Soluble beta-glucan (SBG)

2

PLACEBO COMPARATOR

Drug: Placebo comparator

Interventions

Soluble beta-glucan (SBG) DRUG

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

1

Placebo comparator DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotec Pharmacon ASA: lead

Study Sites (11)

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

Royal Blackburn Hospital

Blackburn, BB2 3LR, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

NHS Greater Glasgow and Clyde Victoria

Glasgow, G42 9TY, United Kingdom

Location

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Location

Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

Location

North Manchester Hospital

Manchester, M8 5RB, United Kingdom

Location

Newcastle General Hospital

Newcastle, NE1 4LP, United Kingdom

Location

Northampton General Hospital

Northampton, NN1 5BD, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Study Officials

• William Jeffcoate, MD, PhD

  Nottingham City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 10, 2008
• Study Start: March 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 26, 2010

Record last verified: 2010-01

Locations

GB (11)