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

February 3, 2009 updated by: BioSyntech Canada Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Center Col Belcher Hospital
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 2K1
        • Surrey Memorial Hospital Fraser Health Authority
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 1R4
        • Dermadvance Research
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Infection Control Unit, Infectious Diseases and Medical Microbiology, University of Manitoba Health Sciences Centre
    • Newfoundland and Labrador
      • Gander, Newfoundland and Labrador, Canada, A1V 1P7
        • James Paton Memorial Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Queen Elizabeth II Health Sciences Centre
      • Sydney River, Nova Scotia, Canada, B1S 3N1
        • Riverside Professional Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8R 2R3
        • The Mayer Institute
      • Kenora, Ontario, Canada, P9N 1Y9
        • Wassay Gezhig Na Nahn Dah We Igamig
      • London, Ontario, Canada, N6C 5J1
        • Parkwood Hospital
      • Mississauga, Ontario, Canada, L4Y1A6
        • Dermatology Clinic
      • Newmarket, Ontario, Canada, L3Y 2R2
        • EntraLogix Clinical Group
      • Toronto, Ontario, Canada, M5C 1R8
        • St Michael's Hospital
      • Toronto, Ontario, Canada, M5S 1B5
        • Dermatology Daycare and Wound Healing Clinic
    • Quebec
      • Boucherville, Quebec, Canada, J4B 5E4
        • Centre podiatrique
      • Gatineau, Quebec, Canada, J8T 7W3
        • Clinique de dermatologie Giard & Toscano, 500 Greber #110
      • Laval, Quebec, Canada, H7T 2P5
        • Centre de recherche clinique de Laval
      • Levis, Quebec, Canada, G6V 3Z1
        • CHAU-Hôtel-Dieu de Lévis, Département de médecine de jour- 5ème étage, Clinique des plaies complexes
      • Montreal, Quebec, Canada, H2W 1T8
        • CHUM - Hotel Dieu
      • St-Jerome, Quebec, Canada, J7Z 5T3
        • St-Jerome Medical Research Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage of subjects with closed ulcers at week 12

Secondary Outcome Measures

Outcome Measure
Reduction in size of the diabetic foot ulcer at week 20.
Safety by analysis of AEs.
Reduction of incidence of clinical signs of infection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Alberto Restrepo, M.D., Medical Monitor, BioSyntech Canada Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

February 9, 2007

First Submitted That Met QC Criteria

February 9, 2007

First Posted (Estimate)

February 13, 2007

Study Record Updates

Last Update Posted (Estimate)

February 5, 2009

Last Update Submitted That Met QC Criteria

February 3, 2009

Last Verified

February 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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