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First received: November 13, 2023

Clinical Trial: Prospective, Multicenter, RCT of the Tenex Ultrasound System

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: Diabetic Foot Ulcer

Study Type: INTERVENTIONAL


Official Title: Prospective, Multicenter, Randomized, Controlled Clinical Trial of the Tenex Ultrasound System (TXB MicroTip) for Wound Care in Patients With Wagner Type 1-2 Diabetic Foot Ulcers (DFUs)

Brief Summary: The goal of this multicenter randomized controlled trial is compare standard of care (SOC) to Tenex MicroTip ultrasound therapy plus SOC in patients with Wagner 1-2 diabetic foot ulcers.The main outcomes to answer are:Does the use of the TXB MicroTip plus SOC increase complete wound healing in Wagner 1-2 diabetic foot ulcer (DFUs) vs. SOC only at 12 weeks (end of treatment)?Does the use of the TXB MicroTip plus SOC increase complete wound healing in Wagner 1-2 DFUs vs. SOC over a subsequent to treatment 12 month…

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