A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.

Detailed Description
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Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys.

Official Title
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A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

Conditions
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Foot Ulcer, Diabetic

Intervention / Treatment
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* Device: PriMatrix
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women ≥ 18 years of age and able to give their own consent Type I or Type II diabetes with investigator-confirmed reasonable metabolic control Study ulcer has a Wagner grade of 1 or 2 Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement A full thickness diabetic foot ulcer located on the foot or ankle An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening. Exclusion Criteria: Suspected or confirmed signs/symptoms of wound infection Wounds with exposed bone or tendon Hypersensitivity to bovine collagen

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>PriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy. | Device: PriMatrix<br>* Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy<br>|
| Active Comparator: Standard of Care<br>Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained. | Other: Standard of Care<br>* Following sharp debridement, moist wound therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of study ulcers healed | Percent of study ulcers healed at week 12 post-randomization | 12 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of Treatment |  | 12 weeks |