Foot Ulcer
Conditions
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.
Interventions
Sponsors
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of wound closure | — |
| Ease of use and adverse events | — |
| Wound odor | — |
| Quality of life | — |
| Wound characteristics | — |
Countries
United States
Outcome results
None listed