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| Name | Class |
|---|---|
| Acesso Biologics | UNKNOWN |
| New Horizon Medical Solutions | NETWORK |
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The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.
This clinical registry is an observational study to collect prospective and retrospective data on subjects' health, wounds and wound care procedures from medical centers, including skilled nursing facilities, hospitals, outpatient clinics, Home Health and any other medical environment where wounds are treated.
The registry will enroll data of up to 5000 subjects in up to 100 wound care locations. The dataset includes all wound and ulcer types. Investigators will follow Institutional standards for routine wound care practices. The study products supplied through this study will be applied to the wounds as an adjunct to the standard of care treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wound Treatment | Interventions are at the discretion of treating clinicians and include standard and advanced wound therapies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Various types of wound care treatments | Combination Product | Treatments including, but not limited to:
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage wound area reduction over time while receiving study product using wound imaging device software or measurement scale | Analysis will be based on product type (e.g., hydrocolloid, amniotic-based, etc.) and wound type (e.g., DFU, VLU, etc.) | Up to 12 weeks |
| Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events (AEs) related to wounds, and device-related adverse events (DRAEs) | Note: Analysis will be based on product type (e.g., hydrocolloid, amniotic-based, etc.) and wound type (e.g., DFU, VLU, etc.) | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of wounds achieving complete closure over time | Up to 12 weeks | |
| Time to achieve complete wound closure while receiving study product | Up to 12 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Care setting analysis for each type of care setting, the number of wounds per type of wound and severity of wound per year | example: 20 severe DFUs per year | Up to 12 weeks |
| Care setting analysis for the duration of stay of wound (weeks) per type of admission |
Inclusion Criteria
Exclusion Criteria
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Adults with wounds/injuries
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulse Cardiovascular Institute | Scottsdale | Arizona | 85251 | United States | ||
| Metro Foot & Ankle |
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| Label | URL |
|---|---|
| Wound care management market overview, 2017, By GlobalData Healthcare | View source |
| Advanced Wound Care Market by Product Type (Infection Management, Exudate Management, Active Wound Care, Therapy Devices), Application (Chronic Wounds and Acute Wounds), End User (Hospitals and Community Centers)... | View source |
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Data collected and analyzed will be marketed to researchers and manufacturers.
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| Assessment of patient reported wound-related pain using a numeric pain rating scale of 0 (no pain) to 10 (worst possible pain) during study product application |
| Up to 12 weeks |
| Up to 12 weeks |
| Economic comparison of treatment cost of wounds treated with Advanced biological/synthetic grafts. versus wounds treated with other treatments using classifications of wound type and medical center | Up to 12 weeks |
| Incidence of infection | Up to 12 weeks |
| Incidence of wound recurrence | Up to 1 year |
| Number of treatment applications | Up to 12 weeks |
| Percentage of wounds that closed during study product application that had previous therapy failure | Up to 12 weeks |
| Proportion of subjects adherent to standard of care therapy | example: compression or offloading compliance as determined by the Investigator at each study visit | Up to 12 weeks |
| Tempe |
| Arizona |
| 85282 |
| United States |
| Pima Foot and Ankle Surgery LLC | Tucson | Arizona | 85718 | United States |
| Signature Health Medical Group | Riverside | California | 92503 | United States |
| The Schottenstein Center | Hallandale | Florida | 33009 | United States |
| PerfectFeetCare Podiatry Centers | Hialeah | Florida | 33012 | United States |
| The Schottenstein Center | Miami | Florida | 33137 | United States |
| PerfectFeetCare Podiatry Centers | Miami | Florida | 33175 | United States |
| Wigley Feet | North Miami Beach | Florida | 33162 | United States |
| Rubin Foot & Ankle | Naperville | Illinois | 60563 | United States |
| The Rache Clinic | Las Vegas | Nevada | 89147 | United States |
| Richard C. Galperin, DPM, PA | Dallas | Texas | 75208 | United States |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D002056 | Burns |
| D014647 | Varicose Ulcer |
| D000081084 | Accidental Injuries |
| D000069836 | Degloving Injuries |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017695 | Soft Tissue Injuries |
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