Proven wound care evidence for Clinical Research
Delivering the evidence you need for a successful trial.
Silhouette® is an easy to use wound imaging, 3D measurement, and documentation system using non-invasive laser technology. As an FDA approved medical device, Silhouette has been proven to provide accurate, precise, and repeatable wound assessments for all phases of clinical research in more than 70 studies globally.
High Quality Data
- Silhouette enables users to easily and quickly gather accurate and repeatable assessment data to prove study endpoints, and make defensible cases for regulatory approval.
- Patient, visit, and wound level notes are customizable to meet data collection requirements.
- Silhouette provides comprehensive and transparent reporting, ensuring the credibility of data throughout your study.
- Data precision and efficiency mitigate risks in evidence collection for clinical trials.
Easy to Use
- SilhouetteStar captures wound images and 3D measurements including area, volume, depth, and perimeter using innovative and proprietary technology superior to other methods.
- Data is instantly available through SilhouetteConnect, enabling timely review and assessment to quickly determine subject inclusion/exclusion.
- SilhouetteCentral increases the efficiency of data collection by centralizing the data, and providing Sponsors, CROs, and other key stakeholders with immediate access to the data gathered at the investigative sites.
- One-click reports, graphs, and custom note fields make it easy for researchers to analyze and track healing progress.
- Silhouette has gathered evidence for successful FDA approvals, to support significant funding for phase progression, and for studies published in peer-reviewed publications.
- Silhouette is the preferred wound assessment and documentation solution for wound studies in the US and globally.
- Silhouette has been used in a multitude of wound studies, including:
- Diabetic Foot Ulcers (DFU), Venous Leg Ulcers (VLU), Arterial Leg Ulcers (ALU), and Pressure Ulcers (PU).
- Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Epidermolysis Bullosa, and Critical Limb Ischemia.
- Pre-clinical through Phase IV studies.
- Assessing Pharmaceutical, Biological, Wound Dressing, and Medical Device products.
- Multi-center and multi-national studies.
- Clinical trials that range in size from 1 to 250 investigator sites.
- Human, porcine, equine, and rodent studies.