Diabetic Foot UlcerPhase 3NCT00434538
BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
A Phase 3 study testing BST-DermOn in people with Diabetic Foot Ulcer, run by BioSyntech Canada Inc. at 20 sites in Canada.
Trial summary
This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers. The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- BST-DermOn
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 20 sitesCanada
- Study dates
- Feb 2007to Nov 2008
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between eighteen (18) and eighty (80) years of age
- Type 1 or Type 2 diabetes mellitus
- Diabetes is under adequate control
- Diabetic foot ulcer located on the mid or forefoot
- Diabetic foot ulcer has been present for at least four (4) weeks and no more than two (2) years prior to screening
- Diabetic foot ulcer is ≥ 1.0cm² and ≤10cm² in size
- Diabetic foot ulcer is grade 1 or 2 according to the Wagner Grading system.
Who cannot join
- Ulcer is over an active Charcot deformity of the mid-foot ("Rocker-Bottom Foot") or over the talus, distal calcaneous, navicular, or cuboid bones or a deformity that interfere with off-loading in the opinion of the investigator
- Ulcer due to a non-diabetic aetiology
- Ulcer has tunnels or sinus tracts that cannot be completely debrided.
- Clinical evidence of infection
- Osteomyelitis
- Subject has vasculitis, severe rheumatoid arthritis, other collagen or vascular diseases or other medical conditions, outside of diabetes, known to impair wound healing.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Canada20 sites
Centre podiatrique
Boucherville, Quebec, J4B 5E4
Foothills Medical Center Col Belcher Hospital
Calgary, Alberta, T2N 2T9
James Paton Memorial Hospital
Gander, Newfoundland and Labrador, A1V 1P7
Clinique de dermatologie Giard & Toscano, 500 Greber #110
Gatineau, Quebec, J8T 7W3
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
The Mayer Institute
Hamilton, Ontario, L8R 2R3
Wassay Gezhig Na Nahn Dah We Igamig
Kenora, Ontario, P9N 1Y9
Centre de Recherche Clinique de Laval
Laval, Quebec, H7T 2P5
CHAU-Hôtel-Dieu de Lévis, Département de médecine de jour- 5ème étage, Clinique des plaies complexes
Lévis, Quebec, G6V 3Z1
Parkwood Hospital
London, Ontario, N6C 5J1
Dermatology Clinic
Mississauga, Ontario, L4Y1A6
CHUM - Hotel Dieu
Montreal, Quebec, H2W 1T8
EntraLogix Clinical Group
Newmarket, Ontario, L3Y 2R2
St-Jerome Medical Research Inc.
Saint-Jérôme, Quebec, J7Z 5T3
Surrey Memorial Hospital Fraser Health Authority
Surrey, British Columbia, V3V 2K1
Riverside Professional Centre
Sydney River, Nova Scotia, B1S 3N1
St Michael's Hospital
Toronto, Ontario, M5C 1R8
Dermatology Daycare and Wound Healing Clinic
Toronto, Ontario, M5S 1B5
Infection Control Unit, Infectious Diseases and Medical Microbiology, University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
Dermadvance Research
Winnipeg, Manitoba, R3C 1R4
About this study
Official title: A Multicenter, Prospective, Randomized Comparison Study of BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers.
The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers.
Read the detailed description
This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers. BST-DermOn is a sterile, non-toxic, nonpyrogenic wound dressing composed of an aqueous mixture of Chitosan, hydrochloric acid (HCl) and disodium beta-glycerol phosphate (β-GP) designed to address current wound healing needs. Chitosan has well documented wound healing properties as well as inherent haemostatic and bacteriostatic capabilities. BST-DermOn is used in conjunction with a defined standard of care and is applied over a prepared and debrided ulcer and covered with a semi-occlusive secondary dressing.
This prospective, multi-center, randomized, controlled study will enrol 130 type 1 or type 2 diabetic subjects presenting with a Grade 1 or Grade 2 (Wagner classification) diabetic foot ulcer of 1-10cm² on the mid or forefoot. Subjects who meet the eligibility criteria will be assigned to one of two groups:
- a control group that will receive the standard of care or
- a treatment group that will receive BST-DermOn.
Treatments in both groups will be applied three (3) times a week for up to twenty consecutive weeks or until the study ulcer is closed. All subjects will be followed for safety and efficacy during treatment visits through a final evaluation visit. There will be a post treatment follow-up visit at 4 weeks post-closure for subjects with complete re-epithelialization.
The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- BST-DermOn
- Keywords
- Diabetic, Foot, Ulcer, Neuropathic, Chitosan
- Medical subject headings
- Diabetic Foot, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BST-DermOnDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with closed ulcers at week 12
Secondary outcomes (3)
Reduction in size of the diabetic foot ulcer at week 20.
Safety by analysis of AEs.
Reduction of incidence of clinical signs of infection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Due to Sponsor's financial reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioSyntech Canada Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alberto Restrepo, M.D., Study director, Medical Monitor, BioSyntech Canada Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434538
- Sponsor's protocol ID
- DO-CIP01-P
- Status last verified
- Feb 2009
- First submitted
- 9 Feb 2007
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Comparison Study of BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00434538
- Acronym / sponsor ID
- DO-CIP01-P
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic, Foot, Ulcer, Neuropathic, Chitosan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Sponsor's financial reasons
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BioSyntech Canada Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 13 Feb 2007 (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.
This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers.
The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers.
Detailed description
This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers. BST-DermOn is a sterile, non-toxic, nonpyrogenic wound dressing composed of an aqueous mixture of Chitosan, hydrochloric acid (HCl) and disodium beta-glycerol phosphate (β-GP) designed to address current wound healing needs. Chitosan has well documented wound healing properties as well as inherent haemostatic and bacteriostatic capabilities. BST-DermOn is used in conjunction with a defined standard of care and is applied over a prepared and debrided ulcer and covered with a semi-occlusive secondary dressing.
This prospective, multi-center, randomized, controlled study will enrol 130 type 1 or type 2 diabetic subjects presenting with a Grade 1 or Grade 2 (Wagner classification) diabetic foot ulcer of 1-10cm² on the mid or forefoot. Subjects who meet the eligibility criteria will be assigned to one of two groups:
- a control group that will receive the standard of care or
- a treatment group that will receive BST-DermOn.
Treatments in both groups will be applied three (3) times a week for up to twenty consecutive weeks or until the study ulcer is closed. All subjects will be followed for safety and efficacy during treatment visits through a final evaluation visit. There will be a post treatment follow-up visit at 4 weeks post-closure for subjects with complete re-epithelialization.
The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between eighteen (18) and eighty (80) years of age
- Type 1 or Type 2 diabetes mellitus
- Diabetes is under adequate control
- Diabetic foot ulcer located on the mid or forefoot
- Diabetic foot ulcer has been present for at least four (4) weeks and no more than two (2) years prior to screening
Key exclusion criteria (6 listed)
- Ulcer is over an active Charcot deformity of the mid-foot ("Rocker-Bottom Foot") or over the talus, distal calcaneous, navicular, or cuboid bones or a deformity that interfere with off-loading in the opinion of the investigator
- Ulcer due to a non-diabetic aetiology
- Ulcer has tunnels or sinus tracts that cannot be completely debrided.
- Clinical evidence of infection
- Osteomyelitis
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 |
|---|---|---|
| BST-DermOn | Device | – |
Primary outcome
Percentage of subjects with closed ulcers at week 12
3 secondary outcomes
Reduction in size of the diabetic foot ulcer at week 20.
Safety by analysis of AEs.
Reduction of incidence of clinical signs of infection.
Results and safety
The study was stopped early (reason given: Due to Sponsor's financial reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
- Sponsor websiteLink provided by the sponsor.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Alberto Restrepo, M.D. study director
Medical Monitor, BioSyntech Canada Inc
20 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 BST-DermOn in people with Diabetic Foot Ulcer, run by BioSyntech Canada Inc. at 20 sites in Canada.
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 6 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: stopped early, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Canada. 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 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 was stopped early (reason given: Due to Sponsor's financial reasons). Results are not available in the source record.
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?
Percentage of subjects with closed ulcers at week 12. It is what the study was designed to measure, not a finding.
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 5 Feb 2009.