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OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.
Wound types will be Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OASIS Wound Matrix (Oasis) | Active Comparator | This is a single arm study with only the test article Oasis used on all subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OASIS Wound Matrix | Device | OASIS (an acellular biomaterial that supports tissue repair with a scaffold-like matrix having a natural structure and composition). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and weekly up to 12 weeks |
| 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). | baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W. Payne, M.D. | Bay Pines VA Healthcare System | Principal Investigator |
| Carl Van Gils, DPM, CWS | Dixie Regional Medical Center Wound Clinic | Principal Investigator |
| Davin Haraway, DO | Sparks Regional Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sparks Regional Medical Center | Fort Smith | Arkansas | 72901 | United States | ||
| Bay Pines VA Healthcare System |
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| ID | Title | Description |
|---|---|---|
| FG000 | OASIS Wound Matrix (Oasis) | All subjects in this study were treated with Oasis®, there were no other test articles used in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OASIS Wound Matrix (Oasis) | All subjects in this study were treated with Oasis®, there were no other test articles used in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Analysis was Per Protocol | Posted | Mean | Standard Deviation | cm2 | Baseline and weekly up to 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OASIS Wound Matrix (Oasis) | All subjects in this study were treated with Oasis®, there were no other test articles used in this study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Follicular swelling | Infections and infestations | MedDRA 12.0 | Systematic Assessment | Infected insect bite - not related to test article |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Herbert B. Slade, M.D., FAAAI | Healthpoint, Ltd. | 917-900-4000 | bert.slade@healthpoint.com |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| St Louis |
| Missouri |
| United States |
| Dixie Regional Medical Center Wound Clinic | St. George | Utah | 84770 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Wound Type | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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). | Analysis was Per Protocol | Posted | Number | Percent of Wounds Closed | baseline and 12 weeks |
|
|
|
| 0 |
| 13 |
| 6 |
| 13 |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment | not related to test article |
|
| Infection left foot 1st metatarsal head | Infections and infestations | MedDRA 12.0 | Systematic Assessment | Injury - not related to test article |
|
| Osteomyelitis left foot 1st metatarsal head | Infections and infestations | MedDRA 12.0 | Systematic Assessment | Osteomyelitis - not related to test article |
|
| Cellulitis left foot ulcer | Infections and infestations | MedDRA (12.0) | Systematic Assessment | Cellulitis of the foot, non-test ulcer - not related to the test article |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment | Head wound - not related to test article |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment | Biopsy pain - not related to test article |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment | Right leg pain - not related to test article |
|
| Blister 2nd toe, left foot, with loose nail | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment | Blister - not related to test article |
|
| Achilles tendon repair | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment | Tendon operation - not related to test article |
|
| Ulcer - right foot 5th toe medially | Vascular disorders | MedDRA 12.0 | Systematic Assessment | Skin ulcer - non-target ulcer - not related to test article |
|
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D014648 | Varicose Veins |