Diabetic Foot Ulcer, Surgical Wound Dehiscence, Traumatic Wounds, Venous Leg Ulcer
Conditions
Brief 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.
Detailed description
The purpose of this clinical investigation is to assess the clinical performance of the Medaxis debritom+ versus standard of care (sharp debridement using scalpel) in the real world practice of wound care management in a single center trial by collecting data on wound healing rates over time, success of advanced wound care treatments, and downstream financial costs in the treatment of diabetic foot ulcers, venous leg ulcers, dehisced surgical wounds and traumatic wounds. Medaxis debritom+TM is an advanced micro fluid jet FDA registered Class II device, which will be used within the cleared intended use of wound therapy.
Interventions
DEVICEStudy Device Debridement
debritom+ water jet debridement
DEVICESOC Debridement
Sharp Scalpel
Sponsors
NAMSA
Medaxis, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Prescribing Physician will be blinded. A site blinded physician will confirm the Prescribing Physician's initial assessment of wound healing and a final blinded Independent Adjudicator will review baseline and final images to assess and provide confirmation of healing.
Intervention model description
Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT). Control and Treatment Arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Potential subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization: 1. At least 18 years old. 2. 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. 3. The index wound is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1. 4. Subject understands and is willing to participate in the clinical study and can comply with weekly visits. 5. 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. DFU 6. Presence of diabetic foot ulcer (DFU) that meets all of the following features: 7. Wagner Grade 1 or 2 (see Appendix A for definitions), including wounds that extend to the ligament, tendon, joint capsule or fascia 8. Without abscess or osteomyelitis 9. The index ulcer will be the largest ulcer if two or more DFUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2cm distant from index ulcer (edge to edge). 10. The index ulcer has been offloaded for at least 14 days prior to randomization 11. 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. VLU 12. All wounds using the CEAP VLU Classification, except for those in the
Exclusion criteria
. (See Appendix A for definitions) 13. 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. 14. 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. Surgical Dehisced 15. All wounds using the Sandy Grading System, except those in the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Closure | 20 weeks | Time to heal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Advanced Wound Care Treatments | 20 weeks | Number of successful advanced wound care treatments placed (eg. Negative Pressure Wound Therapy /grafts) |
| Complications | 20 weeks | Incidence of all index wound-related complications (eg. cellulitis or Infection), hospitalization, wound recurrence |
| Cost | 20 weeks | Cost of Treatment (including Advance Wound Care) and including any index wound-related, event-driven complications using patient records or Medicare reimbursement method. |
| Healed Proportion | 20 weeks | Proportion of wounds completely healed |
Other
| Measure | Time frame | Description |
|---|---|---|
| AWC Failure | 20 weeks | Number of failures in regard to advanced wound care treatments |
| PAR | 20 weeks | Percent Area Reduction of Wound |
| Unhealed Proportion | 20 weeks | Proportion of wounds not completely healed |
Countries
United States
Contacts
Primary ContactSharona Segal-Leibovich
Backup ContactAmy Jo Johnson
Outcome results
None listed