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

NCT ID: NCT00434538

Last Updated: 2009-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-11-30

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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

BST-DermOn

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioSyntech Canada Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Alberto Restrepo, M.D.

Role: STUDY_DIRECTOR

Medical Monitor, BioSyntech Canada Inc

Locations

Foothills Medical Center Col Belcher Hospital

Calgary, Alberta, Canada

Surrey Memorial Hospital Fraser Health Authority

Surrey, British Columbia, Canada

Infection Control Unit, Infectious Diseases and Medical Microbiology, University of Manitoba Health Sciences Centre

Winnipeg, Manitoba, 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

Riverside Professional Centre

Sydney River, Nova Scotia, Canada

The Mayer Institute

Hamilton, Ontario, Canada

Wassay Gezhig Na Nahn Dah We Igamig

Kenora, Ontario, Canada

Parkwood Hospital

London, Ontario, Canada

Dermatology Clinic

Mississauga, Ontario, Canada

EntraLogix Clinical Group

Newmarket, Ontario, Canada

St Michael's Hospital

Toronto, Ontario, Canada

Dermatology Daycare and Wound Healing Clinic

Toronto, Ontario, Canada

Centre podiatrique

Boucherville, Quebec, Canada

Clinique de dermatologie Giard & Toscano, 500 Greber #110

Gatineau, Quebec, 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

Lévis, Quebec, Canada

CHUM - Hotel Dieu

Montreal, Quebec, Canada

St-Jerome Medical Research Inc.

Saint-Jérôme, Quebec, Canada

Countries

Canada

Related Links

http://www.biosyntech.com

Sponsor website

Other Identifiers

DO-CIP01-P

Identifier Type: -

Identifier Source: org_study_id