A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | August 2010 |
To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without
significantly compromised arterial circulation.
Inclusion Criteria:
- Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
- Peripheral neuropathy
- A full thickness diabetic plantar foot ulcer of at least 1 cm2 but not exceeding 10
cm2 in area
- 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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