Foot UlcerPhase 2NCT00288392
Efficacy of Soluble Beta-1,3/1,6-Glucan Compared to Placebo on Chronic Leg Ulcers in Diabetes Patients
A Phase 2 study testing Soluble beta-1,3/1,6-glucan in people with Foot Ulcer, run by Biotec Pharmacon ASA at 2 sites in Russia.
Trial summary
The purpose of this study is to evaluate the efficacy of soluble beta-1,3/1,6-glucan compared to placebo on the healing of chronic leg ulcers in diabetes patients. Hypothesis: Through its ability to activate tissue macrophages and counteract diabetes-associated defects in macrophages, the soluble beta-1,3/1,6-glucan… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer
- What is being tested?
- Soluble beta-1,3/1,6-glucan
- How many people
- 60 participants
- Where
- 2 sitesRussia
- Study dates
- Jun 2005to Sep 2006
- Phase
- Phase 2
- 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
- Study wound is a Wagner Grade 1 partial thickness or Grade 2 full thickness lesion but without exposed tendon, joint, or bones
- Study wound located on the foot or lower leg
- Study wound must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years
- Adequate circulation to the foot, evidenced by a palpable pulse on the study foot
- Study wound > 1.0cm2 but < 20.0cm2
- Written informed consent
Who cannot join
- Pregnancy, lactation or absence of adequate contraception for fertile women
- Ankle/Brachial Index < 0.7
- Severe malnutrition
- Clinical evidence of gangrene on any part of the foot with the study wound
- Active or extensive cellulitis extending more than 1 cm beyond wound margin and/or presence of cellulitis with purulent discharge on day 0
- One or more medical condition(s) that in the opinion of the investigator would make the patient an inappropriate candidate for the study
Show all 15Show fewer
- Active osteomyelitis of the foot with the study wound
- Necrotic toes on the foot with the study wound
- Surgical procedure (other than debridement) on the foot with the study wound the last 21 days prior to screening
- Study wound over a Charcot's joint
- Evidence of deep tissue infection of the study wound at day 0
- Non-study wound on the study foot that is located within 5.0cm from the study wound at day 0
- Random blood sugar reading > 450 mg/dL
- Alcohol or drug abuse
- Participation in other clinical studies in the last 4 weeks
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Municipal Healthcare Institution 1st City Clinical Hospital
Arkhangelsk, 163061
St. Petersburg State Institution Saint Martyr Elezabeth Hospital
Saint Petersburg, 195257
About this study
Official title: A Double-Blind Therapeutic Exploratory Clinical Study to Evaluate the Efficacy of Soluble Beta-1,3/1,6-Glucan Compared to Placebo on Chronic Leg Ulcers in Diabetes Patients
The purpose of this study is to evaluate the efficacy of soluble beta-1,3/1,6-glucan compared to placebo on the healing of chronic leg ulcers in diabetes patients.
Hypothesis: Through its ability to activate tissue macrophages and counteract diabetes-associated defects in macrophages, the soluble beta-1,3/1,6-glucan will promote the healing of leg ulcers in diabetic patients.
Read the detailed description
Diabetes predisposes to ulceration of the foot through a variety of processes, including neuropathy and peripheral arterial disease. Once the skin is broken, healing is frequently delayed and the ulcer develops the biology of a chronic wound. The factors underlaying delayed healing in chronic wounds are not well understood but include the effects of repeated trauma, tissue ischemia, infection, defective white cell function, altered immune processes, and altered expression of tissue cytokines and enzymes.
Management is based on regular cleansing and debridement, off-loading and treatment of intercurrent infection with antibiotics. There are no interventions in routine use, which target aspects of chronic wound biology directly.
- Conditions
- Foot Ulcer
- Being tested
- Soluble beta-1,3/1,6-glucan
- Medical subject headings
- Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble beta-1,3/1,6-glucanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- Time to healing
Secondary outcomes (4)
Number of patients with complete healing of treated ulcers after 12 weeks of treatment
Percentage reduction in ulcer area of treated ulcers after 12 weeks of treatment
Percentage weekly reduction in ulcer area in treated ulcers
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startJun 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foot UlcerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Biotec Pharmacon ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tatyana Zykova, Dr.med., Principal investigator, Municipal Healthcare Institution 1st City Hospital, Department of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288392
- Sponsor's protocol ID
- SBG-1-11
- Status last verified
- May 2006
- First submitted
- 7 Feb 2006
- Last updated
- 18 Oct 2006
- Results posted
- No
Publications
Zykova SN, Balandina KA, Vorokhobina NV, Kuznetsova AV, Engstad R, Zykova TA. Macrophage stimulating agent soluble yeast beta-1,3/1,6-glucan as a topical treatment of diabetic foot and leg ulcers: A randomized, double blind, placebo-controlled phase II study. J Diabetes Investig. 2014 Jul;5(4):392-9. doi: 10.1111/jdi.12165. Epub 2013 Dec 2.
PubMed 25411598
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Therapeutic Exploratory Clinical Study to Evaluate the Efficacy of Soluble Beta-1,3/1,6-Glucan Compared to Placebo on Chronic Leg Ulcers in Diabetes Patients
- ClinicalTrials.gov ID
- NCT00288392
- Acronym / sponsor ID
- SBG-1-11
- Conditions
- Foot Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Biotec Pharmacon ASAIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Sep 2006
- First posted
- 8 Feb 2006 (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 evaluate the efficacy of soluble beta-1,3/1,6-glucan compared to placebo on the healing of chronic leg ulcers in diabetes patients.
Hypothesis: Through its ability to activate tissue macrophages and counteract diabetes-associated defects in macrophages, the soluble beta-1,3/1,6-glucan will promote the healing of leg ulcers in diabetic patients.
Detailed description
Diabetes predisposes to ulceration of the foot through a variety of processes, including neuropathy and peripheral arterial disease. Once the skin is broken, healing is frequently delayed and the ulcer develops the biology of a chronic wound. The factors underlaying delayed healing in chronic wounds are not well understood but include the effects of repeated trauma, tissue ischemia, infection, defective white cell function, altered immune processes, and altered expression of tissue cytokines and enzymes.
Management is based on regular cleansing and debridement, off-loading and treatment of intercurrent infection with antibiotics. There are no interventions in routine use, which target aspects of chronic wound biology directly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 1 or Type 2 diabetes mellitus
- Age>= 18 years
- Study wound is a Wagner Grade 1 partial thickness or Grade 2 full thickness lesion but without exposed tendon, joint, or bones
- Study wound located on the foot or lower leg
- Study wound must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years
Key exclusion criteria (15 listed)
- Pregnancy, lactation or absence of adequate contraception for fertile women
- Ankle/Brachial Index < 0.7
- Severe malnutrition
- Clinical evidence of gangrene on any part of the foot with the study wound
- Active or extensive cellulitis extending more than 1 cm beyond wound margin and/or presence of cellulitis with purulent discharge 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-1,3/1,6-glucan | Drug | – |
Primary outcome
- Time to healing
4 secondary outcomes
Number of patients with complete healing of treated ulcers after 12 weeks of treatment
Percentage reduction in ulcer area of treated ulcers after 12 weeks of treatment
Percentage weekly reduction in ulcer area in treated ulcers
Safety
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 18 Oct 2006.
- Derived from this study: PubMed 25411598Zykova SN, Balandina KA, Vorokhobina NV, Kuznetsova AV, Engstad R, Zykova TA. Macrophage stimulating agent soluble yeast beta-1,3/1,6-glucan as a topical treatment of diabetic foot and leg ulcers: A randomized, double blind, placebo-controlled phase II study. J Diabetes Investig. 2014 Jul;5(4):392-9. doi: 10.1111/jdi.12165. Epub 2013 Dec 2.
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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.
Tatyana Zykova, Dr.med. principal investigator
Municipal Healthcare Institution 1st City Hospital, Department of Endocrinology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Soluble beta-1,3/1,6-glucan in people with Foot Ulcer, run by Biotec Pharmacon ASA at 2 sites in Russia.
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 8 inclusion and 15 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 18 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
- Time to healing. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00288392, which also lists 1 linked publication.
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 18 Oct 2006.