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

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BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
This study is currently recruiting participants.
Verified by BioSyntech Canada Inc., February 2007
Sponsored by: BioSyntech Canada Inc.

Information provided by: BioSyntech Canada Inc.
ClinicalTrials.gov Identifier: NCT00434538

Purpose
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.

Condition Intervention Phase
Diabetic Foot Ulcer
Device: BST-DermOn
Phase III

MedlinePlus related topics: Diabetic Foot Foot Health
Drug Information available for: Chitosan
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:A Multicenter, Prospective, Randomized Comparison Study of BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

Further study details as provided by BioSyntech Canada Inc.:

Primary Outcome Measures:
Percentage of subjects with closed ulcers at week 12

Secondary Outcome Measures:
Reduction in size of the diabetic foot ulcer at week 20.

Safety by analysis of AEs.

Reduction of incidence of clinical signs of infection.

Estimated Enrollment:130
Study Start Date:February 2007

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:

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.

Eligibility
Ages Eligible for Study:18 Years to 80 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
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.
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434538

Locations
Canada, Alberta
Foothills Medical Center Col Belcher Hospital Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Bonnie McCardale 403-944-8673 bonnie.mccardale@calgaryhealthregion.ca
Principal Investigator: Laurie Michelle Parsons, MD
Canada, British Columbia
Surrey Memorial Hospital Fraser Health Authority Recruiting
Surrey, British Columbia, Canada, V3V 2K1
Contact: Hellen Elliot 604-587-3744
Principal Investigator: Yazdan Mirzanejad, MD
Canada, Manitoba
Infection Control Unit, Infectious Diseases and Medical Microbiology, University of Manitoba Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: John Manuel Anthony Embil, MD, FRCPC (204) 787 3868 jembil@hsc.mb.ca
Contact: Loraine Kuzyk, RN
Principal Investigator: John Manuel Anthony Embil, MD, FRCPC
Dermadvance Research Terminated
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, Newfoundland and Labrador
James Paton Memorial Hospital Recruiting
Gander, Newfoundland and Labrador, Canada, A1V 1P7
Contact: Delilah Guy 709-424-1322
Principal Investigator: John Haggie, MD
Canada, Nova Scotia
Riverside Professional Centre Recruiting
Sydney River, Nova Scotia, Canada, B1S 3N1
Contact: Theresa Arsenault 902-539-0055 theresaarsenault@hotmail.com
Principal Investigator: Marc-Antoine Despatis, MD
Queen Elizabeth II Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Cathy Burrows 902-473-8539
Principal Investigator: Gerald MacKean, MD
Canada, Ontario
Dermatology Clinic Recruiting
Mississauga, Ontario, Canada, L4Y1A6
Contact: Patricia Coutts, RN (905) 273 9009 ext 22 patcoutts@rogers.com
Principal Investigator: G Sibbald, MD, FRCPC
Dermatology Daycare and Wound Healing Clinic Recruiting
Toronto, Ontario, Canada, M5S 1B5
Contact: Sunita Coehlo 416-323-6407 Sunita.coehlo@wchospital.ca
Principal Investigator: Gary Sibbald, MD
Parkwood Hospital Recruiting
London, Ontario, Canada, N6C 5J1
Contact: Lise Goettl 519-685-4024 lise.goettl@sjhc.london.on.ca
Principal Investigator: David Keast, MD
Wassay Gezhig Na Nahn Dah We Igamig Recruiting
Kenora, Ontario, Canada, P9N 1Y9
Contact: Jennifer Roberts 807-467-8770 Jroberts@Kahac.org
Principal Investigator: Jennifer Roberts
St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5C 1R8
Contact: Laura Teague 416-360-4000 ext 2376 teaguel@smh.toronto.on.ca
Principal Investigator: Timothy Rudolf Daniels, MD
EntraLogix Clinical Group Recruiting
Newmarket, Ontario, Canada, L3Y 2R2
Contact: Theresa Hurd 905-898-0716
Principal Investigator: Sylvia Garnis-Jones
The Mayer Institute Recruiting
Hamilton, Ontario, Canada, L8R 2R3
Contact: Shelley Furtado 905-523-1444 shelley.tmi@gmail.com
Contact: Kristen Johnston 905-523-1444 kristen.tmi@gmail.com
Principal Investigator: Perry Mayer, M.D.
Canada, Quebec
Centre de Recherche Clinique de Laval Recruiting
Laval, Quebec, Canada, H7T 2P5
Contact: Sylvie Gauthier, RN (450) 688-4340 crcl@crcl2001.com
Principal Investigator: Richard Dumas, MD
St-Jerome Medical Research Inc. Recruiting
St-Jerome, Quebec, Canada, J7Z 5T3
Contact: Laurie Delves 450-431-1020 ext 21 ldelves@stjerome-medicalresearch.ca
Contact: Veronique Sardin 450-431-1020 ext 42 vsardin@stjerome-medicalresearch.ca
Principal Investigator: Yves Pesant, M.D.
Centre podiatrique Recruiting
Boucherville, Quebec, Canada, J4B 5E4
Contact: Christina Morin, DPM 450-655-7155 centrepodiatrique@bellnet.ca
Principal Investigator: Christina Morin, DPM
Clinique de dermatologie Giard & Toscano, 500 Greber #110 Recruiting
Gatineau, Quebec, Canada, J8T 7W3
Contact: Françoise Giard, MD, FRCPC 819-561-5554 francoise.giard@sympatico.ca
Contact: Francine D'Auray, RN 819-561-5554
Principal Investigator: Françoise Giard, MD, FRCPC
CHUM - Hotel Dieu Recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Josee Des Cormiers 514-890-8000 ext 12910 josee.descormiers.chum@ssss.gouv.qc.ca
Principal Investigator: Jean-Marie Ekoe, MD
CHAU-Hôtel-Dieu de Lévis, Département de médecine de jour- 5ème étage, Clinique des plaies complexes Recruiting
Levis, Quebec, Canada, G6V 3Z1
Contact: Mario Côté, MD, CCMF(MU) 418-835-7121 ext 1393 mariocote3@videotron.ca
Principal Investigator: Mario Côté, MD, CCMF(MU)
Sub-Investigator: Richard Belley, MD, CCMF

Sponsors and Collaborators
BioSyntech Canada Inc.
Investigators
Study Director: Alberto Restrepo, M.D. Medical Monitor, BioSyntech Canada Inc

More Information

Sponsor website

Study ID Numbers:DO-CIP01-P
First Received:February 9, 2007
Last Updated:April 15, 2008
ClinicalTrials.gov Identifier:NCT00434538 [history]
Health Authority:Canada: Health Canada

Keywords provided by BioSyntech Canada Inc.:
Diabetic
Foot
Ulcer
Neuropathic
Chitosan

Study placed in the following topic categories:
Foot Ulcer
Skin Diseases
Diabetic Neuropathies
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases
Diabetic Angiopathies
Chitosan
Endocrinopathy
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases