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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00434538
• Other study ID #: DO-CIP01-P
• Status: Terminated
• Phase: Phase 3
• First received: February 9, 2007
• Last updated: February 3, 2009
• Start date: February 2007
• Est. completion date: November 2008

Study information

• Verified date: February 2009
• Source: BioSyntech Canada Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• BST-DermOn

Locations

Country	Name	City	State
Canada	Centre podiatrique	Boucherville	Quebec
Canada	Foothills Medical Center Col Belcher Hospital	Calgary	Alberta
Canada	James Paton Memorial Hospital	Gander	Newfoundland and Labrador
Canada	Clinique de dermatologie Giard & Toscano, 500 Greber #110	Gatineau	Quebec
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	The Mayer Institute	Hamilton	Ontario
Canada	Wassay Gezhig Na Nahn Dah We Igamig	Kenora	Ontario
Canada	Centre de Recherche Clinique de Laval	Laval	Quebec
Canada	CHAU-Hôtel-Dieu de Lévis, Département de médecine de jour- 5ème étage, Clinique des plaies complexes	Levis	Quebec
Canada	Parkwood Hospital	London	Ontario
Canada	Dermatology Clinic	Mississauga	Ontario
Canada	CHUM - Hotel Dieu	Montreal	Quebec
Canada	EntraLogix Clinical Group	Newmarket	Ontario
Canada	St-Jerome Medical Research Inc.	St-Jerome	Quebec
Canada	Surrey Memorial Hospital Fraser Health Authority	Surrey	British Columbia
Canada	Riverside Professional Centre	Sydney River	Nova Scotia
Canada	Dermatology Daycare and Wound Healing Clinic	Toronto	Ontario
Canada	St Michael's Hospital	Toronto	Ontario
Canada	Dermadvance Research	Winnipeg	Manitoba
Canada	Infection Control Unit, Infectious Diseases and Medical Microbiology, University of Manitoba Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
BioSyntech Canada Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with closed ulcers at week 12
Secondary	Reduction in size of the diabetic foot ulcer at week 20.
Secondary	Safety by analysis of AEs.
Secondary	Reduction of incidence of clinical signs of infection.