Status:
TERMINATED
BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
Lead Sponsor:
BioSyntech Canada Inc.
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ...
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 dres...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00434538
Start Date
February 1 2007
End Date
November 1 2008
Last Update
February 5 2009
Active Locations (20)
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1
Foothills Medical Center Col Belcher Hospital
Calgary, Alberta, Canada, T2N 2T9
2
Surrey Memorial Hospital Fraser Health Authority
Surrey, British Columbia, Canada, V3V 2K1
3
Infection Control Unit, Infectious Diseases and Medical Microbiology, University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
4
Dermadvance Research
Winnipeg, Manitoba, Canada, R3C 1R4