Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will compare the Omeza® Products Bundle to standard of care (SOC) for in subjects with chronic venous leg ulcers and subjects with diabetic foot ulcers.
This is a randomized, multi-center, open-label study comparing the Omeza® Products Bundle versus standard of care treatments for 2 different types of chronic ulcers (venous leg ulcers and diabetic foot ulcers). The treatment period will be 12 weeks, with subjects coming into the study site weekly for evaluations, photography and formal measurements of the target wound, and dressing changes. There will be a total of 13 study site visits. The Screening Visit (Day 0) will occur 1 week prior to randomization and will include routine labs and vascular assessment to determine inclusion/exclusion of the potential subject from the study; followed by weekly treatment visits (Week 1 through Week 11); randomization will occur at Treatment Visit Week 1; the Treatment Visit Week 12/End of Study Visit will include end of study labs. Target wounds will be photographed and measured, and vascular assessment will be done at each of the 13 visits.
If the wound closes before Week 12, the subject will continue to come in for all the remaining study visits until study completion. If the wound does not close by Week 12, the subject will be immediately exited from the study and no further follow-up will occur as part of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omeza Value-based Bundle Test | Active Comparator | The Omeza value-based bundle consists of lidocaine lavage, flowable collagen matrix and skin protectant products. |
|
| Standard Wound Care Control | Active Comparator | Standard wound care control is saline wound wash and wet to dry dressing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound dressing | Device | Clean wound, fill wound, dress wound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Closure | Percent wound closure from baseline | 13 weeks |
| Wound Closure Rate | Rate of wound closure measured weekly | 13 weeks |
| Time to Maximum Wound Closure | Number of weeks to achieve complete wound closure | 1-13 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luba Lavrik | Contact | 561-200-3344 | 4438 | LLavrik@PalmBeachCRO.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrew J Applewhite, MD,CWSP,FUHM | Baylor University Medical Center's Comprehensive Wound Center | Principal Investigator |
| David Swain, DPM,CWSP | First Coast Cardiovascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Coast Cardiovascular Institute | Recruiting | Jacksonville | Florida | 32256 | United States |
Not provided
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
Not provided
Not provided
| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Robert B McLafferty, MD,MBA,FACS | Oregon Health and Science University | Principal Investigator |
| Jacob Reinkraut, DPM,FACFAS | Saint Michael's Medical Center | Principal Investigator |
| Saint Michael's Medical Center | Recruiting | Newark | New Jersey | 07102 | United States |
|
| Oregon Health & Science University (OHSU) | Recruiting | Portland | Oregon | 97239 | United States |
|
| Baylor Scott & White Comprehensive Wound Care Center | Recruiting | Dallas | Texas | 75246 | United States |
|
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |