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Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ActiGraft | Whole blood clot (WBC) gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActiGraft | Device | Whole blood clot (WBC) gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage area reduction (PAR) at 4 weeks | Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT). | 4 weeks |
| Nature, frequency, and severity of adverse events in the intent to treat population | Nature, frequency, and severity (by CTCAE5) of adverse events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage area reduction at 8 and 12 weeks | Change from baseline at 8 and 12 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in pain at 4 weeks | Pain reduction at 4 weeks for wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT) for patients reporting any level of wound related pain (>1 on a VAS scale of 0-10 points) at baseline | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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Patients with all types of exuding cutaneous wound
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharon Sirota | Contact | +972545800765 | sharon@reddress.co.il |
| Name | Affiliation | Role |
|---|---|---|
| Sharon Sirota | RedDress Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wound Care Experts | Recruiting | Las Vegas | Nevada | 89128 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35881826 | Derived | Williams M, Davidson D, Wahab N, Hawkins J, Wachuku CD, Snyder R. Innovative treatment utilizing an autologous blood clot for diabetic foot ulcers. Wounds. 2022 Jul;34(7):195-200. doi: 10.25270/wnds/21089. |
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The results will be part of several scientific publications
Upon publication
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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