BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Prospective, Randomized Comparison Study of BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: BST-DermOn


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BST-DermOn|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with closed ulcers at week 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic, Foot, Ulcer, Neuropathic, Chitosan