Pilot Trial for WounDx™ Clinical Decision Support Tool (NCT06921707)
SC2i-WounDx-001-WounDx™ Pilot Trial: Proof of Concept Feasibility for the Clinical Operations of WounDx™ in Aiding Clinicians Identify Wounds That Are Ready For Surgical Closure
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this research is to evaluate the overall use of the WounDx medical device in a clinical setting, such as a hospital. The WounDx device is experimental and not yet approved by the United States Food and Drug Administration (FDA). WounDx uses information about a patient's wound to generate a report that a surgeon may use to help determine when to close or not close the wound. The final decision to close the wound remains with the surgeon. The results from this pilot trial will inform a larger pivotal trial.
Who can join: Review the eligibility criteria below.
Location: University of Alabama - Birmingham Hospital — Birmingham, Alabama
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- University of Alabama - Birmingham Hospital — Birmingham, Alabama
- Emory University / Grady Memorial Hospital — Atlanta, Georgia
- Indiana University Health University Hospital — Indianapolis, Indiana
- Duke University Hospital — Durham, North Carolina
- Brooke Army Medical Center — Fort Sam Houston, Texas
📞 Contact the Study Coordinator
Phone: (301) 295-3017
Email: eric.elster@usuhs.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Wounds
- A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing. — Castro Valley, California
- 4-aminopyridine for Skin Wound Healing — Tucson, Arizona
- A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing — San Francisco, California
Explore by condition: All Wounds clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.