Prospective, Multicenter, RCT of the Tenex Ultrasound System

NCT06137222 | Unknown DMC FDA Device

• 1 other identifier: TenexInc
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

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 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

Keywords

DFU, healing, Wagner Classification

Outcome Measures

Primary Outcomes (2)

• Wager 1-2 DFU healing. Primary outcome endpoint.

  Incidence of index ulcers closed by 12 weeks, where healing has been confirmed 2 weeks after the investigator considers the ulcer healed. The definition of a completely healed DFU is: Intact skin, meaning complete epithelialization without any drainage of a previously ulcerated site

  12 weeks

• Incidence of adverse events (AEs) and serious adverse events (SAEs). Primary safety endpoint

  Adverse events are defined as: mild (asymptomatic or mild symptoms, clinical or diagnostic observation only; intervention not indicated); moderate (local or non-invasive intervention indicated; limitations to age appropriate activities of daily living); serious/severe: death, life threatening, hospitalization or prolongation of hospitalization is indicated, persistent or significantly disabling event

  12 weeks

Secondary Outcomes (2)

• Durability of healing as measured by incidence of re-ulceration within a 12 month follow up period.

  12 months

• Wound size (area in cm2) reduction from baseline/treatment initiation

  12 weeks

Study Arms (2)

SOC plus TXB MicroTip Ultrasound

EXPERIMENTAL

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.

Device: Tenex TXB MicroTip Ultrasound system plus SOC

SOC

PLACEBO COMPARATOR

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

Interventions

Tenex TXB MicroTip Ultrasound system plus SOC DEVICE

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).

SOC plus TXB MicroTip Ultrasound

Standard of Care for diabetic foot ulcer OTHER

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

SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Documented history of Type I or Type II Diabetes Mellitus requiring oral and/or insulin replacement therapy
• Presence of a DFU Wagner 1 - 2 grade wound on any aspect of the foot, provided it is at or below the medial malleolus.
• If other wounds are present on the same foot, they must be more than 2 cm distant from the index ulcer.
• Index ulcer (post-debridement) is a minimum of 1.0 cm2 and a maximum of 10 cm2 at screening visit and treatment visit. The area of the DFU index ulcer is to be measured via the CarePics platform (also see Appendix for explanation of what CarePics does).
• Adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) measurement of ≥ 30 or an Ankle Branchial Index (ABI) of ≥ 0.7 and ≤ 1.2 or; Arterial Doppler with a minimum of biphasic flow or; Toe Brachial Index (TBI) ≥ 0.75 , using the affected study extremity within 30 days of screening or; great toe pressure \>50mmHg.
• Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
• Properly obtained written informed consent
• Subject must have stable living environment in order to manage offloading and wound care management.

You may not qualify if:

• Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening and baseline/treatment initiation visit. Note: Baseline/treatment initiation visit should be no more than 10 days after screening. If baseline/treatment initiation visit \>10 days after screen, rescreen patient.
• Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \> 10mg prednisone (or equivalent daily dose), cytotoxic chemotherapy, or who are anticipated to require such medications during the study.
• Index ulcer treated within the last 30 days prior to screening with a prohibited treatment or throughout the trial:
• Negative pressure therapies
• Hyperbaric Oxygen
• Any cellular and/or tissue-based products or wound dressings that include growth factors (e.g., EpiFix®, Regranex, Dermagraft®, Apligraf®, GraftJacket™, OASIS®, PriMatrix®)
• Active Charcot's arthropathy of the index ulcer limb as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to screening.
• Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment including offloading.
• Subjects with osteomyelitis on the same limb as the index ulcer as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to screening. Note that with Wagner 1 DFUs, an Xray or MRI would be required for diagnosis of osteomyelitis. For Wagner 2 DFUs, an MRI would be required for diagnosis of osteomyelitis.
• Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 60 days of screening.
• Subjects with end stage renal disease on hemodialysis.
• Infected index ulcer at screening. Note: Patient can be rescreened once the infection is deemed clinically resolved.
• 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.

Sponsors & Collaborators

• Tenex Health Inc.: lead
• Trice Medical: collaborator

Study Sites (2)

Springhill Medical Center

Mobile, Alabama, 36608, United States

Location

St. George Regional Hospital

St. George, Utah, 84770, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Carl Van Gils, DPM

  St. George Regional Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey D Voigt, MBA/MPH

CONTACT

201-790-1521; meddevconsultant@aol.com

Carl Van Gils, DPM

CONTACT

435-628-2671; drvangils@feetnet.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, randomized controlled clinical trial.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: December 4, 2023
• Primary Completion: March 31, 2024
• Study Completion: December 4, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (2)