Tenex Ultrasound Therapy for Diabetic Foot

Recruiting at 1 trial location

Overseen By Carl Van Gils, DPM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tenex Health Inc.

Must be taking: Oral diabetes medications, Insulin

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Gangrene, Charcot's arthropathy, Osteomyelitis, others

Compensation: Varies

Number of Visits: 37

Duration: 12 weeks

148 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants or certain treatments for your ulcer, you may need to stop those.

What data supports the effectiveness of the Tenex Ultrasound System treatment for diabetic foot?

Research shows that ultrasound therapy can significantly improve the healing rate of diabetic foot ulcers. In one study, 40.7% of patients receiving ultrasound therapy experienced complete healing compared to 14.3% in the control group, indicating its potential effectiveness in treating these types of wounds. ^{1 2 3 4 5}

Is Tenex Ultrasound Therapy safe for humans?

Research on similar ultrasound therapies for diabetic foot ulcers shows they are generally safe, with no significant difference in adverse events compared to control groups. ^{1 5 6 7 8}

How does Tenex Ultrasound Therapy differ from other treatments for diabetic foot ulcers?

Tenex Ultrasound Therapy is unique because it uses ultrasound waves to promote healing by enhancing blood flow and reducing bacterial load in diabetic foot ulcers, unlike traditional treatments that primarily focus on wound care and offloading pressure. ^{1 5 8 9 10}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either SOC or SOC plus TXB MicroTip ultrasound therapy for diabetic foot ulcers

12 weeks

12 visits (weekly, in-person)

Follow-up

Participants are monitored monthly for durability of wound healing after treatment

12 months

12 visits (monthly, in-person)

Crossover Treatment (if applicable)

SOC patients who have not healed at 12 weeks may receive Tenex therapy for an additional 12 weeks

12 weeks

12 visits (weekly, in-person)

Treatment Details

Interventions

• Tenex Ultrasound System

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+

Findings from Research

In a study of 210 patients, those receiving MIST Therapy in addition to standard wound care had a significantly higher healing rate (53%) compared to those receiving only standard care (32%).

MIST Therapy also resulted in a faster healing rate, with a steeper regression slope (1.4) compared to the control group (0.22), indicating that this therapy enhances the effectiveness of standard wound care for chronic lower-extremity wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expedited wound healing with noncontact, low-frequency ultrasound therapy in chronic wounds: a retrospective analysis. Kavros, SJ., Liedl, DA., Boon, AJ., et al.[2008]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. [2005]

2. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of ultrasound-guided steroid injections for pain management of midfoot joint degenerative disease. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effect of ultrasound-supported wound debridement in subjects with diabetic foot ulcers: A meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

How effective is therapeutic ultrasound in the treatment of heel pain? [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Expedited wound healing with noncontact, low-frequency ultrasound therapy in chronic wounds: a retrospective analysis. [2008]

6. China pubmed.ncbi.nlm.nih.gov

[Preliminary Application of Contrast-Enhanced Ultrasound in the Treatment of Diabetic Ulcers]. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Extracorporeal shock wave therapy for the treatment of plantar fasciitis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Case report: Successful treatment of human diabetic foot ulcer using low-intensity diagnostic ultrasound combined with microbubbles: Two cases. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Treatment of ischemic wounds with noncontact, low-frequency ultrasound: the Mayo clinic experience, 2004-2006. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

Ultrasound in the Modern Management of the Diabetic Foot Syndrome: A Multipurpose Versatile Toolkit. [2021]