Tenex Ultrasound Therapy for Diabetic Foot
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to determine if adding a special ultrasound treatment, called Tenex MicroTip, to usual care can heal diabetic foot ulcers more effectively than usual care alone. It targets individuals with Type 1 or Type 2 diabetes who have foot wounds that are not too deep. Participants will receive weekly treatments for up to 12 weeks, followed by monthly follow-ups for a year to monitor healing. This study suits those with a stable living environment who can attend regular appointments. As an unphased trial, it offers a unique opportunity to contribute to medical research and potentially experience innovative treatment benefits.
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 prior data suggests that the Tenex Ultrasound System is safe for treating diabetic foot ulcers?
Research has shown that the Tenex Ultrasound System is generally safe for treating diabetic foot ulcers. This system uses a tool called the TXB MicroTip, which makes a small cut to remove damaged tissue and aid healing. This method may help wounds heal faster and with fewer complications.
A review of several studies found that using ultrasound to treat wounds can improve healing in diabetic foot ulcers. The Tenex system uses sound waves to gently remove unhealthy tissue, potentially aiding better and quicker healing. This technique is designed to be safe and effective, aiming to reduce the chance of the wound returning.
Overall, patients generally tolerate the Tenex Ultrasound System well, with no widespread reports of serious side effects. However, like any procedure, there can be some risks, such as mild pain or discomfort at the treatment site. Patients should discuss any concerns with healthcare providers to determine if this treatment is suitable.12345Why are researchers excited about this trial?
Unlike the standard of care for diabetic foot ulcers, which typically involves regular debridement and wound care, the Tenex Ultrasound System introduces an innovative approach by using ultrasound technology to target and remove damaged tissue precisely. This method is unique because it combines sharp debridement with a single percutaneous ultrasound-assisted debridement, aiming to enhance healing. Researchers are excited about this treatment because it could lead to faster and more effective wound closure, reducing the risk of complications and improving patient outcomes. The use of ultrasound might promote better healing through its precision and potential to stimulate tissue repair, setting it apart from traditional methods.
What evidence suggests that the Tenex Ultrasound System is effective for diabetic foot ulcers?
Research has shown that Tenex Ultrasound therapy, which participants in this trial may receive, might heal diabetic foot ulcers more effectively than standard care alone. Studies have found that the TXB MicroTip, a tool used in this therapy, helps remove dead tissue and speeds up healing. Patients using this treatment have seen their wounds close faster and remain healed without the ulcers returning. The therapy is minimally invasive, meaning it’s a simpler procedure that doesn’t require major surgery. Overall, early evidence suggests that adding this ultrasound treatment can improve healing for diabetic foot ulcers.12367
Who Is on the Research Team?
Carl Van Gils, DPM
Principal Investigator
St. George Regional Hospital
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either SOC or SOC plus TXB MicroTip ultrasound therapy for diabetic foot ulcers
Follow-up
Participants are monitored monthly for durability of wound healing after treatment
Crossover Treatment (if applicable)
SOC patients who have not healed at 12 weeks may receive Tenex therapy for an additional 12 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Tenex Ultrasound System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tenex Health Inc.
Lead Sponsor
Trice Medical
Industry Sponsor