Study Stopped
Due to Sponsor's financial reasons
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
1 other identifier
interventional
40
1 country
20
Brief 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 diabetic foot ulcers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2007
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 9, 2007
CompletedFirst Posted
Study publicly available on registry
February 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedFebruary 5, 2009
February 1, 2009
1.8 years
February 9, 2007
February 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Foothills Medical Center Col Belcher Hospital
Calgary, Alberta, T2N 2T9, Canada
Surrey Memorial Hospital Fraser Health Authority
Surrey, British Columbia, V3V 2K1, Canada
Infection Control Unit, Infectious Diseases and Medical Microbiology, University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
Dermadvance Research
Winnipeg, Manitoba, R3C 1R4, Canada
James Paton Memorial Hospital
Gander, Newfoundland and Labrador, A1V 1P7, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
Riverside Professional Centre
Sydney River, Nova Scotia, B1S 3N1, Canada
The Mayer Institute
Hamilton, Ontario, L8R 2R3, Canada
Wassay Gezhig Na Nahn Dah We Igamig
Kenora, Ontario, P9N 1Y9, Canada
Parkwood Hospital
London, Ontario, N6C 5J1, Canada
Dermatology Clinic
Mississauga, Ontario, L4Y1A6, Canada
EntraLogix Clinical Group
Newmarket, Ontario, L3Y 2R2, Canada
St Michael's Hospital
Toronto, Ontario, M5C 1R8, Canada
Dermatology Daycare and Wound Healing Clinic
Toronto, Ontario, M5S 1B5, Canada
Centre podiatrique
Boucherville, Quebec, J4B 5E4, Canada
Clinique de dermatologie Giard & Toscano, 500 Greber #110
Gatineau, Quebec, J8T 7W3, Canada
Centre de Recherche Clinique de Laval
Laval, Quebec, H7T 2P5, Canada
CHAU-Hôtel-Dieu de Lévis, Département de médecine de jour- 5ème étage, Clinique des plaies complexes
Lévis, Quebec, G6V 3Z1, Canada
CHUM - Hotel Dieu
Montreal, Quebec, H2W 1T8, Canada
St-Jerome Medical Research Inc.
Saint-Jérôme, Quebec, J7Z 5T3, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alberto Restrepo, M.D.
Medical Monitor, BioSyntech Canada Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 9, 2007
First Posted
February 13, 2007
Study Start
February 1, 2007
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
February 5, 2009
Record last verified: 2009-02