RecruitingNot ApplicableNCT06921707

Pilot Trial for WounDx™ Clinical Decision Support Tool

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

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Enrollment

40 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Wounds Wounds and Injuries Traumatic Wounds and Injuries Extremity Injury Amputation, Traumatic/Surgery Amputation, Wound Open Fracture Wounds

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Clinical Decision Support Tool and a procedure called Standard of Care (SOC) for people with amputation, traumatic/surgery, amputation, wound, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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