Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center (EVIDENT)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer; Surgical Wound Dehiscence; Traumatic Wounds
• Intervention / Treatment: Device: Study Device Debridement; Device: SOC Debridement

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharona Segal-Leibovich; Phone Number: 646-369-1570; Email: ssegal-leibovich@namsa.com
• Study Contact Backup: Name: Amy Jo Johnson; Email: amyjo.johnson@medaxis.us

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34208
      • Recruiting
      • MCR Health, Inc.
      • Contact: Melvin B Price, DPM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 exclusion criteria. (See Appendix A for definitions)

    Traumatic

16. 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)

Exclusion Criteria:

General

Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization:

1. The index wound, in the opinion of the investigator, is suspicious for cancer or have a positive carcinoma diagnosis.
2. 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.
3. Subject is taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.
4. Subject is on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
5. History of radiation at the wound site (regardless of time since last radiation treatment).
6. Index wound has been previously treated or will need to be treated with any prohibited therapies (See Section 6 of this protocol for a list of prohibited medications and therapies).
7. Subject has a previous diagnosis of HIV, Hepatitis C, or other contagious diseases.
8. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or the subject has a known history of poor adherence with medical treatment.
9. Subject is pregnant or breast-feeding.
10. Presence of diabetes with poor metabolic control as documented with an HbA1c >12.0 % within 90 days of randomization.
11. Subject has end-stage renal disease as evidenced by a serum creatinine > 3.0mg/dL within 6 months of randomization.
12. BMI >55
13. PAR experiences a >30% change between SV1 and SV2 DFU
14. Wagner 2 wounds that require debridement of bone.

15. Osteomyelitis or bone infection of the affected foot as verified by x-ray, CAT Scan, or MRI within 30 days prior to randomization (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).

    VLU

16. Exclude

    1. Secondary post thrombotic
    2. Venous Obstruction
    3. Venous Obstruction with reflux
    4. Lipodermato sclerosis or atrophic blanche

17. Osteomyelitis or bone infection of the affected leg as verified by x-ray, CAT Scan, or MRI within 30 days prior to randomization (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).

    Surgical Dehisced

18. Using the Sandy Grading System for Surgical Wound Dehiscence: Wounds Grade 3 where organs are exposed, and 3a, where the infection is severe as deemed by the Principal Investigator.

    Traumatic

19. Using CDC Surgical Wound Classification, exclude

    1. Class IV - dirty infected wounds
    2. SSI - Deep incisional and organ space

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: debritom+; Group 1: Medaxis debritom+	Device: Study Device Debridement; debritom+ water jet debridement
Active Comparator: Sharp Scalpel; Group 2: SOC (Sharp Scalpel Debridement)	Device: SOC Debridement; Sharp Scalpel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Closure	Time to heal	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Incidence of all index wound-related complications (eg. cellulitis or Infection), hospitalization, wound recurrence	20 weeks
Advanced Wound Care Treatments	Number of successful advanced wound care treatments placed (eg. Negative Pressure Wound Therapy /grafts)	20 weeks
Cost	Cost of Treatment (including Advance Wound Care) and including any index wound-related, event-driven complications using patient records or Medicare reimbursement method.	20 weeks
Healed Proportion	Proportion of wounds completely healed	20 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unhealed Proportion	Proportion of wounds not completely healed	20 weeks
PAR	Percent Area Reduction of Wound	20 weeks
AWC Failure	Number of failures in regard to advanced wound care treatments	20 weeks

Collaborators and Investigators

• Sponsor: Medaxis, LLC
• Collaborators: NAMSA
• Investigators: Principal Investigator: Melvin B Price, DPM, MCR Health Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Varicose Veins; Diabetic Neuropathies; Foot Diseases; Surgical Wound; Ulcer; Varicose Ulcer; Leg Ulcer; Wounds and Injuries; Diabetic Foot; Foot Ulcer; Surgical Wound Dehiscence
• Other Study ID Numbers: MEDX-DT-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No