Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center (NCT04920253) | Clinical Trial Compass
RecruitingNot Applicable
Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
United States180 participantsStarted 2021-11-29
Plain-language summary
Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as a choice of debridement method, where both arms follow normal wound care practice in use of advanced wound care treatments.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 18 years old.
✓. The index wound (i.e. current episode of the wound or ulceration) has been present for greater than 4 weeks prior to SV 1 and has had less than 1 year of documented medical treatment, as of the subject's consent for the study participation.
✓. The index wound is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1.
✓. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
✓. Subject must have read and signed the IRB approved Informed Consent Form (ICF) before study specific screening procedures that are not standard of care are undertaken.
✓. Presence of diabetic foot ulcer (DFU) that meets all of the following features:
✓. Wagner Grade 1 or 2 (see Appendix A for definitions), including wounds that extend to the ligament, tendon, joint capsule or fascia
✓. Without abscess or osteomyelitis
Exclusion criteria
✕3. The index ulcer will be the largest ulcer if two or more VLUs are present and will be the only one evaluated in the study. If other Ulcerations are present on the same leg, they must be more than 2cm distant from index ulcer.
✕4. Adequate circulation to the affected foot as documented by a Clarifi SFDI Vascular Assessment Tool, or an Ankle Brachial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed, evaluating for bi-phasic dorsalis pedis and posterior tibial vessels at the level of the ankle within 3 months of SV1 or if monophasic wave forms present must have adequate micro circulation as evidenced by Clarifi SFDI Vascular Assessment Tool. Note: A documented record of an ABI test performed using the index ulcer leg, within 3 months of SV1 is acceptable for the purposes of this study. Otherwise, this must be completed in the Screening Visit. Acceptable alternatives include arterial Doppler ultrasound evaluating vessels at the level of the ankle, or documented adequate microcirculation as determined by a Clarifi SFDI Vascular Assessment Tool.
✕5. All wounds using the Sandy Grading System, except those in the exclusion criteria. (See Appendix A for definitions)
✕6. All wounds as per the CDC Surgical Wound Classification, with the exception of Class IV or dirty infected wounds, SSI - Deep incisional and organ space. (See Appendix A for definitions)
✕. The index wound, in the opinion of the investigator, is suspicious for cancer or have a positive carcinoma diagnosis.
✕. Subject has a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the wound surface within 1 month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.
✕. Subject is taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.
✕. Subject is on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.