Status:
UNKNOWN
Prospective, Multicenter, RCT of the Tenex Ultrasound System
Lead Sponsor:
Tenex Health Inc.
Collaborating Sponsors:
Trice Medical
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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 outc...
Detailed Description
Subjects will be randomized in a 1:1 ratio to receive either: • Sharp debridement of the outer margins of the index DFU using standard technique (curettage or sharp blade debridement) plus a single a...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 4 2025
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06137222
Start Date
December 4 2023
End Date
December 4 2025
Last Update
November 18 2023
Active Locations (2)
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1
Springhill Medical Center
Mobile, Alabama, United States, 36608
2
St. George Regional Hospital
St. George, Utah, United States, 84770