A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
| Status: | Terminated |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/3/2017 |
| Start Date: | December 2010 |
| End Date: | September 2017 |
A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
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.
and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with
controlled diabetes mellitus and without significantly compromised arterial circulation.
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.
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.
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
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