- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00434538
BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 2T9
- Foothills Medical Center Col Belcher Hospital
-
-
British Columbia
-
Surrey, British Columbia, Canada, V3V 2K1
- Surrey Memorial Hospital Fraser Health Authority
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3C 1R4
- Dermadvance Research
-
Winnipeg, Manitoba, Canada, R3A 1R9
- Infection Control Unit, Infectious Diseases and Medical Microbiology, University of Manitoba Health Sciences Centre
-
-
Newfoundland and Labrador
-
Gander, Newfoundland and Labrador, Canada, A1V 1P7
- James Paton Memorial Hospital
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 3A7
- Queen Elizabeth II Health Sciences Centre
-
Sydney River, Nova Scotia, Canada, B1S 3N1
- Riverside Professional Centre
-
-
Ontario
-
Hamilton, Ontario, Canada, L8R 2R3
- The Mayer Institute
-
Kenora, Ontario, Canada, P9N 1Y9
- Wassay Gezhig Na Nahn Dah We Igamig
-
London, Ontario, Canada, N6C 5J1
- Parkwood Hospital
-
Mississauga, Ontario, Canada, L4Y1A6
- Dermatology Clinic
-
Newmarket, Ontario, Canada, L3Y 2R2
- EntraLogix Clinical Group
-
Toronto, Ontario, Canada, M5C 1R8
- St Michael's Hospital
-
Toronto, Ontario, Canada, M5S 1B5
- Dermatology Daycare and Wound Healing Clinic
-
-
Quebec
-
Boucherville, Quebec, Canada, J4B 5E4
- Centre podiatrique
-
Gatineau, Quebec, Canada, J8T 7W3
- Clinique de dermatologie Giard & Toscano, 500 Greber #110
-
Laval, Quebec, Canada, H7T 2P5
- Centre de recherche clinique de Laval
-
Levis, Quebec, Canada, G6V 3Z1
- CHAU-Hôtel-Dieu de Lévis, Département de médecine de jour- 5ème étage, Clinique des plaies complexes
-
Montreal, Quebec, Canada, H2W 1T8
- CHUM - Hotel Dieu
-
St-Jerome, Quebec, Canada, J7Z 5T3
- St-Jerome Medical Research Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Percentage of subjects with closed ulcers at week 12
|
Secondary Outcome Measures
Outcome Measure |
---|
Reduction in size of the diabetic foot ulcer at week 20.
|
Safety by analysis of AEs.
|
Reduction of incidence of clinical signs of infection.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alberto Restrepo, M.D., Medical Monitor, BioSyntech Canada Inc
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DO-CIP01-P
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot Ulcer
-
University of MinnesotaRecruitingDiabetes Mellitus | Foot Ulcer | Ulcer | Diabetic Foot Ulcer | Foot Ulcer, Diabetic | Ulcer Foot | Ulcer, Leg | Ankle UlcerUnited States
-
Community Pharmacology Services LtdKeneric HealthcareNot yet recruitingDiabetic Foot Ulcer | Diabetic Foot Ulcer Neuropathic | Diabetic Foot Ulcer Ischemic
-
Johns Hopkins UniversityWithdrawnDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Mixed | Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
-
University of PadovaUnknownDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Deformities FootItaly
-
Corporacion Parc TauliCompletedDiabetic Foot Ulcer | Diabetic Foot Ulcer NeuropathicPakistan
-
Exciton Technologies Inc.CompletedDiabetic Foot Ulcer | Diabetic Foot Infection | Non-healing Diabetic Foot UlcerCanada
-
National and Kapodistrian University of AthensTerminatedDiabetic Foot | Chronic Diabetic Foot Ulcer of Right Foot | Neuropathic Foot Ulcer | Chronic Diabetic Ulcer of Left Foot (Diagnosis)Greece
-
Baylor College of MedicineLifeNet HealthCompletedDiabetic Foot Ulcer | Deep Diabetic Foot UlcerUnited States
-
University of the PunjabHigher Education Commission (Pakistan); Centre of Excellence in Molecular Biology... and other collaboratorsRecruitingDiabetes Mellitus | Diabetic Foot | Foot Ulcer | Diabetes Complications | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Foot Ulcer Due to Type 1 Diabetes Mellitus | Foot Ulcer Due to Type 2 Diabetes Mellitus | Chronic Diabetic Ulcer of Left Foot | Chronic Diabetic Foot...Pakistan
-
ETS Wound Care, LLCProfessional Education and Research InstituteCompletedDiabetic Foot | Diabetic Foot Ulcer | Ulcer FootUnited States
Clinical Trials on BST-DermOn
-
Groupe Francophone des MyelodysplasiesRecruitingAcute Myeloid Leukemia | Myelodysplastic SyndromesFrance
-
Nova Scotia Health AuthorityWithdrawnDisorder of Hip Region
-
Piramal Healthcare Canada LtdSmith & Nephew, Inc.; Global Research SolutionsTerminatedDegenerative Lesion of Articular Cartilage of Knee | Traumatic; LesionSpain, France, Australia, Canada, Germany, Switzerland, United Kingdom
-
Piramal Healthcare Canada LtdCompletedKnee InjuriesKorea, Republic of, Canada, Spain
-
Catholic University of the Sacred HeartCompleted
-
BioSight Ltd.CompletedAcute Myeloid Leukemia | Acute Lymphoblastic LeukemiaIsrael
-
Piramal Healthcare Canada LtdCompletedKnee InjuriesSpain, Canada
-
Jagiellonian UniversityCompleted
-
Jagiellonian UniversityCompleted
-
M.D. Anderson Cancer CenterCompletedProstate CancerUnited States, Canada