Cutaneous Wounds
Conditions
Keywords
DFU, PU, Surgical, Vascular, Trauma
Brief summary
Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.
Interventions
DEVICEActiGraft
Whole blood clot (WBC) gel
Sponsors
RedDress Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Subject is ≥18 years of age * Subject has an exuding cutaneous wound * Subject agrees to the use of his health data, including photos of his wound in analysis and publications * Subject/LAR must be able to read and understand English and/or Spanish
Exclusion criteria
* Subject/LAR is unable to read and understand English or Spanish.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage area reduction (PAR) at 4 weeks | 4 weeks | Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT). |
| Nature, frequency, and severity of adverse events in the intent to treat population | 1 year | Nature, frequency, and severity (by CTCAE5) of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage area reduction at 8 and 12 weeks | 12 weeks | Change from baseline at 8 and 12 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reduction in pain at 4 weeks | 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 |
Countries
United States
Contacts
Primary ContactSharon Sirota
Outcome results
None listed