Diabetic Foot Ulcers (DFU), Venous Stasis Ulcers (VSU)
Conditions
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).
Interventions
DEVICEOASIS Wound Matrix
OASIS (an acellular biomaterial that supports tissue repair with a scaffold-like matrix having a natural structure and composition).
Sponsors
Healthpoint
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First. | 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) |
| Percent Wounds Closed | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OASIS Wound Matrix (Oasis) All subjects in this study were treated with Oasis®, there were no other test articles used in this study. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Missed visits | 1 |
Baseline characteristics
| Characteristic | OASIS Wound Matrix (Oasis) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age Continuous | 63.5 years STANDARD_DEVIATION 17.2 |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 8 Participants |
| Wound Type DFU | 7 Participants |
| Wound Type VSU | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.
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)
Time frame: Baseline and weekly up to 12 weeks
Population: Analysis was Per Protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OASIS Wound Matrix (Oasis) | Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First. | Diabetic Foot Ulcers (DFU) | 1.3 cm2 | Standard Deviation 0.6 |
| OASIS Wound Matrix (Oasis) | Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First. | Venous Stasis Ulcers (VSU) | 3.6 cm2 | Standard Deviation 2.2 |
Primary
Percent Wounds Closed
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).
Time frame: baseline and 12 weeks
Population: Analysis was Per Protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OASIS Wound Matrix (Oasis) | Percent Wounds Closed | Diabetic Foot Ulcers (DFU) | 50.0 Percent of Wounds Closed |
| OASIS Wound Matrix (Oasis) | Percent Wounds Closed | Venous Stasis Ulcers (VSU) | 66.7 Percent of Wounds Closed |