Tenex Ultrasound Therapy for Diabetic Foot

Recruiting at 1 trial location

Overseen by Carl Van Gils, DPM

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Tenex Health Inc.

Trial Summary

What is the purpose of this trial?

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.

Research Team

Carl Van Gils, DPM

Principal Investigator

St. George Regional Hospital

Eligibility Criteria

Adults over 18 with Type I or II Diabetes and a diabetic foot ulcer graded Wagner 1-2 can join this trial. They must have good blood flow to the affected foot, be able to attend weekly treatments for up to 12 weeks, and follow-up monthly for a year. People with poorly controlled diabetes (HbA1c ≥12), on dialysis, infected ulcers, certain bone conditions, gangrene, or who've had recent prohibited treatments cannot participate.

Inclusion Criteria

I have a grade 1 or 2 wound on my foot below my ankle.

Any other wounds on my foot are at least 2 cm away from the main ulcer.

Properly obtained written informed consent

Exclusion Criteria

Any clinically significant finding, in the judgment of the investigator, that would place the subject at health risk, impact the study, or affect the completion of the study

My ulcer or limb has gangrene or unstable blood flow.

I haven't taken strong immune system medications for more than two weeks.

Treatment Details

Interventions

• Tenex Ultrasound System (Procedure)

Trial Overview The study is testing if adding Tenex TXB MicroTip ultrasound therapy to standard care improves healing of diabetic foot ulcers compared to standard care alone. Participants will receive either the combination treatment or just standard care and will be monitored for wound healing at the end of treatment (12 weeks) and over a following year.

Participant Groups

Group I: SOC plus TXB MicroTip Ultrasound Experimental Treatment 1 Intervention

Sharp debridement of the outer margins of the index DFU using standard technique (curettage or sharp blade debridement) plus a single additional percutaneous debridement of bone and surrounding tissue via the TXB MicroTip for the first treatment session only 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.

Group II: SOC Placebo Group 1 Intervention

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).

Who Is Running the Clinical Trial?

Tenex Health Inc.

Lead Sponsor

Trials

1

Recruited

150+

Trice Medical

Industry Sponsor

Trials

1

Recruited

150+