Clinical trial NCT00434538: BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
Official title: A Multicenter, Prospective, Randomized Comparison Study of BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic
Foot
Ulcer
Neuropathic
Chitosan
Lead sponsor: BioSyntech Canada Inc.
Sponsor class: INDUSTRY
First posted: 2007-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of subjects with closed ulcers at week 12
Secondary outcomes:
measure: Reduction in size of the diabetic foot ulcer at week 20.
measure: Safety by analysis of AEs.
measure: Reduction of incidence of clinical signs of infection.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center Col Belcher Hospital
state: Alberta
city: Surrey
country: Canada
facility: Surrey Memorial Hospital Fraser Health Authority
state: British Columbia
city: Winnipeg
country: Canada
facility: Infection Control Unit, Infectious Diseases and Medical Microbiology, University of Manitoba Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Dermadvance Research
state: Manitoba
city: Gander
country: Canada
facility: James Paton Memorial Hospital
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Sydney River
country: Canada
facility: Riverside Professional Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: The Mayer Institute
state: Ontario
city: Kenora
country: Canada
facility: Wassay Gezhig Na Nahn Dah We Igamig
state: Ontario
city: London
country: Canada
facility: Parkwood Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Dermatology Clinic
state: Ontario
city: Newmarket
country: Canada
facility: EntraLogix Clinical Group
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Dermatology Daycare and Wound Healing Clinic
state: Ontario
city: Boucherville
country: Canada
facility: Centre podiatrique
state: Quebec
city: Gatineau
country: Canada
facility: Clinique de dermatologie Giard & Toscano, 500 Greber #110
state: Quebec
city: Laval
country: Canada
facility: Centre de Recherche Clinique de Laval
state: Quebec
city: Levis
country: Canada
facility: CHAU-Hôtel-Dieu de Lévis, Département de médecine de jour- 5ème étage, Clinique des plaies complexes
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Hotel Dieu
state: Quebec
city: St-Jerome
country: Canada
facility: St-Jerome Medical Research Inc.
state: Quebec
Study officials:
affiliation: Medical Monitor, BioSyntech Canada Inc
name: Alberto Restrepo, M.D.
role: STUDY_DIRECTOR
References: