BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
- Conditions
- Diabetic Foot Ulcer
- Registration Number
- NCT00434538
- Lead Sponsor
- BioSyntech Canada Inc.
- 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.
- 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:
1. a control group that will receive the standard of care or
2. 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of subjects with closed ulcers at week 12
- Secondary Outcome Measures
Name Time Method Reduction in size of the diabetic foot ulcer at week 20. Safety by analysis of AEs. Reduction of incidence of clinical signs of infection.
Trial Locations
- Locations (20)
CHUM - Hotel Dieu
🇨🇦Montreal, Quebec, Canada
CHAU-Hôtel-Dieu de Lévis, Département de médecine de jour- 5ème étage, Clinique des plaies complexes
🇨🇦Levis, Quebec, Canada
Centre de Recherche Clinique de Laval
🇨🇦Laval, Quebec, Canada
St-Jerome Medical Research Inc.
🇨🇦St-Jerome, Quebec, Canada
Centre podiatrique
🇨🇦Boucherville, Quebec, Canada
Clinique de dermatologie Giard & Toscano, 500 Greber #110
🇨🇦Gatineau, Quebec, Canada
Foothills Medical Center Col Belcher Hospital
🇨🇦Calgary, Alberta, Canada
Riverside Professional Centre
🇨🇦Sydney River, Nova Scotia, Canada
The Mayer Institute
🇨🇦Hamilton, Ontario, Canada
Surrey Memorial Hospital Fraser Health Authority
🇨🇦Surrey, British Columbia, Canada
Wassay Gezhig Na Nahn Dah We Igamig
🇨🇦Kenora, Ontario, Canada
Infection Control Unit, Infectious Diseases and Medical Microbiology, University of Manitoba Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Parkwood Hospital
🇨🇦London, Ontario, Canada
Dermatology Clinic
🇨🇦Mississauga, Ontario, Canada
Dermatology Daycare and Wound Healing Clinic
🇨🇦Toronto, Ontario, Canada
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
EntraLogix Clinical Group
🇨🇦Newmarket, Ontario, Canada
Dermadvance Research
🇨🇦Winnipeg, Manitoba, Canada
James Paton Memorial Hospital
🇨🇦Gander, Newfoundland and Labrador, Canada
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada