Clinical trial NCT00235196: Evaluation of the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers
Official title: A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foot Ulcer
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on diabetic foot ulcers.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Ambulatory (i.e. walking is the primary method of mobilization. Crutches, walker, walking frame or other ambulation aids are permitted).
* Diagnosed Type 2 diabetic (i.e. not juvenile onset).
* Have a DFU on the plantar surface of either foot.
* Have a DFU of \>4 wks but \<6 months duration.
* Willing and capable of cooperating to the extent and degree required by the study protocol

Exclusion Criteria:

* Be \< 1cm2 or \>10cm2 in area, by planimetry.
* Demonstrate overt signs of infection.
* Be located on the dorsal, lateral, or posterior heel area of the foot (Change 2, Amendment 1).
* Have visible exposed bone or tendon.
* Have an adjacent thermal injury or wound of an etiology other than diabetes.
* Be within 5 cm of any other wound, regardless of etiology.
* Have received enzymatic debriding agents in the past 7 days.
* Have received topical antibiotic therapy in the past 7 days.
* Be less than 1 cm2 or exceed 10cm2 in area by planimetry, after debridement.
* Have exposed bone or tendon, after debridement

The study subject MUST NOT:

* Have received previous treatment for the study ulcer by this Investigator.
* Have more than 3 full thickness ulcers, in total.
* Be pregnant or nursing an infant
* Have a concurrent illness or condition which may interfere with wound healing, such as carcinoma, vasculitis, immune system disorders or connective tissue disorder.
* Be a known alcohol or drug abuser.
* Have received systemic corticosteroids, immunosuppressive or chemotherapeutic agents in the past 30 days.
* Have received radiotherapy, which includes the lower extremity, at any time.
* Have a marked Charcot foot or claw foot deformity which would limit the ability of the subject to wear or be compliant with the wearing of the standardized off-loading device used in this study.
* Have received an investigational drug or device in the past 30 days.
* Have a known hypersensitivity to bovine collagen, oxidized regenerated cellulose (ORC) or silver.
* Be unwilling or unable to be fitted or compliant with the wearing of an ulcer off-loading device.
* Known to be non-compliant or unlikely to complete the study.
* Have ABPI \< 0.7, OR, if ABPI \>1.0 and toe pressure \>0.6.
* Have serum Creatinine \> 3 mg/dL25. have Hgb A1C\>9%

Primary outcomes:
measure: Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups.
Secondary outcomes:
measure: Rate of wound closure
measure: Ease of use and adverse events
measure: Wound odor
measure: Quality of life
measure: Wound characteristics
Other outcomes:
Locations:
city: Ft. Lauderdale
country: United States
facility: Wound Care Center
state: Florida
city: South Miami
country: United States
facility: Foot and Ankle Institute of South Florida
state: Florida
city: Warren
country: United States
facility: Penn North Centers for Advanced Wound Care
state: Pennsylvania
Study officials:
affiliation: Ethicon, Inc.
name: James Hart, MD
role: STUDY_DIRECTOR
References: