Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
BioSyntech Canada Inc. |
---|---|
Information provided by: | BioSyntech Canada Inc. |
ClinicalTrials.gov Identifier: | NCT00434538 |
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 |
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 |
Estimated Enrollment: | 130 |
Study Start Date: | February 2007 |
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:
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Alberto Restrepo, M.D. | Medical Monitor, BioSyntech Canada Inc |
Study ID Numbers: | DO-CIP01-P |
Study First Received: | February 9, 2007 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00434538 |
Health Authority: | Canada: Health Canada |
Diabetic Foot Ulcer Neuropathic Chitosan |
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 |
Pathologic Processes Cardiovascular Diseases |