Chronic Diabetic Foot UlcersPhase 3NCT00632008
Soluble Beta-glucan (SBG) as Treatment for Diabetic Foot Ulcers
A Phase 3 study testing Soluble beta-glucan (SBG) in people with Chronic Diabetic Foot Ulcers, run by Biotec Pharmacon ASA at 11 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Diabetic Foot Ulcers
- What is being tested?
- Soluble beta-glucan (SBG)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- Mar 2007to Oct 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites
Belfast City Hospital
Belfast, BT9 7AB
Royal Blackburn Hospital
Blackburn, BB2 3LR
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Southmead Hospital
Bristol, BS10 5NB
NHS Greater Glasgow and Clyde Victoria
Glasgow, G42 9TY
Leeds General Infirmary
Leeds, LS1 3EX
Leicester General Hospital
Leicester, LE5 4PW
North Manchester Hospital
Manchester, M8 5RB
Newcastle General Hospital
Newcastle, NE1 4LP
Northampton General Hospital
Northampton, NN1 5BD
Nottingham City Hospital
Nottingham, NG5 1PB
About this study
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
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
- Being tested
- Soluble beta-glucan (SBG), Placebo comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Placebo comparatorDrug
Topical application of placebo to wound, at least twice a week until compleate healing or for maximum 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SBG Receives: Drug: Soluble beta-glucan (SBG) |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo comparator |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startMar 2007
- Primary completionAug 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotec Pharmacon ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Jeffcoate, MD, PhD, Principal investigator, Nottingham City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632008
- Sponsor's protocol ID
- SBG-1-12
- Status last verified
- Jan 2010
- First submitted
- 29 Feb 2008
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00632008
- Acronym / sponsor ID
- SBG-1-12
- Conditions
- Chronic Diabetic Foot Ulcers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Biotec Pharmacon ASAIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Soluble beta-glucan (SBG)SBG |
| 2 | Placebo comparator | Drug: Placebo comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soluble beta-glucan (SBG)Topical application of SBG to the wound, at least twice a week until complete healing or for 8 maximum weeks | Drug | 1 |
| Placebo comparatorTopical application of placebo to wound, at least twice a week until compleate healing or for maximum 8 weeks. | Drug | 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
Related trials for Chronic Diabetic Foot Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
RecruitingPhase 3
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Jeffcoate, MD, PhD principal investigator
Nottingham City Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Soluble beta-glucan (SBG) in people with Chronic Diabetic Foot Ulcers, run by Biotec Pharmacon ASA at 11 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2010.