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

This study has been terminated.
(Due to Sponsor's financial reasons)
Sponsor:
Information provided by:
BioSyntech Canada Inc.
ClinicalTrials.gov Identifier:
NCT00434538
First received: February 9, 2007
Last updated: February 3, 2009
Last verified: February 2009

February 9, 2007
February 3, 2009
February 2007
November 2008   (final data collection date for primary outcome measure)
Percentage of subjects with closed ulcers at week 12
Same as current
Complete list of historical versions of study NCT00434538 on ClinicalTrials.gov Archive Site
  • Reduction in size of the diabetic foot ulcer at week 20.
  • Safety by analysis of AEs.
  • Reduction of incidence of clinical signs of infection.
Same as current
Not Provided
Not Provided
 
BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Foot Ulcer
Device: BST-DermOn
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00434538
DO-CIP01-P
No
Not Provided
BioSyntech Canada Inc.
Not Provided
Study Director: Alberto Restrepo, M.D. Medical Monitor, BioSyntech Canada Inc
BioSyntech Canada Inc.
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP