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Prospective, Multicenter, RCT of the Tenex Ultrasound System

NCT06137222 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2023-11-18

No results posted yet for this study

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 follow-up?

Participants will be asked to come in weekly over a 12 week period for treatment of the Wagner 1-2 DFUs til the DFU is healed. Those whose DFU has healed over the 12 week period will be assessed for durability of healing over a subsequent 12 month period (with assessments occurring monthly.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

Tenex TXB MicroTip Ultrasound system plus SOC

Subcutaneous sharp debridement of the index DFU using standard technique (curettage or sharp blade debridement) plus wound care offloading. The index foot ulcer will be dressed with collagen alginate, gauze and roll gauze. Each subject will return for weekly wound assessment, serial sharp debridement if needed and repeat dressing changes. This care will occur for a duration of 12 weeks or until wound closure is confirmed. Defined as standard of care (SOC).

OTHER

Standard of Care for diabetic foot ulcer

Use of standard of care for the treatment of a diabetic foot ulcer

Sponsors & Collaborators

  • Trice Medical

    collaborator INDUSTRY

  • Tenex Health Inc.

    lead INDUSTRY

Principal Investigators

  • Carl Van Gils, DPM · St. George Regional Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2024-03-31
Completion
2025-12-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06137222 on ClinicalTrials.gov