Case Study Documentation of Subjects With Either Diabetic Foot Ulcers or Venous Stasis Ulcers Being Treated With OASIS
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Healthpoint
- Enrollment
- 13
- Locations
- 6
- Primary Endpoint
- Percent Wounds Closed
Study Overview
Brief Summary
OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.
Detailed Description
Wound types will be Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
OASIS Wound Matrix (Oasis)
This is a single arm study with only the test article Oasis used on all subjects
Intervention: OASIS Wound Matrix (Device)
Outcomes
Primary Outcomes
Percent Wounds Closed
Time Frame: baseline and 12 weeks
Wound healing was assessed weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first. The outcome value was based on the percent of wounds which were closed at the end of the study (at 12 weeks). The percent wounds closed were calculated for each wound type: Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).
Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.
Time Frame: Baseline and weekly up to 12 weeks
Wound measurements were made weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first. The final measurement taken was subtracted from the baseline to assess the decrease in wound area after treatment. Final calculation is mean baseline measurement minus final measurement at 12 weeks (or when wound healed, whichever occurred first)
Secondary Outcomes
No secondary outcomes reported