Phase 4
N=13
OASIS Wound Matrix (Oasis) Mechanism of Action
Diabetic Foot Ulcers (DFU) · Venous Stasis Ulcers (VSU)
Bottom Line
View on ClinicalTrials.gov: NCT00570141 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: Primary: Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First. — 1.3; 3.6 cm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- OASIS Wound Matrix (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Healthpoint
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First. |
1.3; 3.6 | — |
| PRIMARY Percent Wounds Closed |
50.0; 66.7 | — |
Summary
OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.
Eligibility Criteria
Inclusion Criteria
- Diabetic foot ulcer (DFU) or venous stasis ulcer (VSU) of the leg, with certain restrictions on size, duration and underlying health
Exclusion Criteria
- Contraindications or hypersensitivity to the use of the study medications or their components
Data sourced from ClinicalTrials.gov (NCT00570141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.