A Prospective, Multi-center Observational Study to Investigate the Safety and Effectiveness of Sterilized, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Foot Ulcer
- Sponsor
- ConvaTec Inc.
- Enrollment
- 30
- Locations
- 5
- Primary Endpoint
- Wound Healing area using digital image
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
A Prospective, Non-Randomized, Multi-Center Observational Study
To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)
Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading
Detailed Description
This is a prospective, multi-center observational study . The trial will include 30 completed subjects at three (3) experienced clinical centers in the United States. The estimated enrollment period is 13 weeks. After completing a screening , the subjects will be enrolled and receive treatment followed for at least 12 weeks. It is expected that the majority of the subjects will be recruited from patients being seen in the Investigators' practices. No minors will be included in the study and it is anticipated that there will be a roughly equal representation of male and female subjects. Further, no subjects will be excluded because of race or ethnicity and all efforts will be made to adequately represent the study population in the area in which they are chosen. All subjects will be used for the analysis of efficacy and safety data.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Index Ulcer Assessment:
- •Penetrates down to muscle, tendon, or bone
- •Presence of another diabetic foot ulcer within 2 cm of the index ulcer
- •Index ulcer determined to be due to Active Charcot deformity or previous surgical correction for Charcot deformity.
- •Wounds which occur in relation to major structural abnormalities of the foot, which would include amputations related to osteomyelitis or Charcot deformity
- •Exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.
- •Known or suspected local skin malignancy to the index diabetic ulcer
- •Wound duration \> one year without intermittent closure
- •Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:
- •In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcer
Outcomes
Primary Outcomes
Wound Healing area using digital image
Time Frame: 12 weeks
The primary endpoint for the study is assessment of ulcer area at Weeks 6 and 12 using the MolecuLight Imaging Device
Secondary Outcomes
- Wound Closure(12 weeks)
- Percentage area reduction(12 weeks)
- Adverse events(12 weeks)