Diabetic Foot Ulcer
Conditions
Keywords
Diabetic, Foot, Ulcer, Neuropathic, Chitosan
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.
Interventions
DEVICEBST-DermOn
Sponsors
BioSyntech Canada Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with closed ulcers at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in size of the diabetic foot ulcer at week 20. | — |
| Safety by analysis of AEs. | — |
| Reduction of incidence of clinical signs of infection. | — |
Countries
Canada
Outcome results
None listed