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

NCT04920253 | Recruiting FDA Device

• 1 other identifier: MEDX-DT-03
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer; Venous Leg Ulcer; Surgical Wound Dehiscence; Traumatic Wounds

Outcome Measures

Primary Outcomes (1)

• Wound Closure

  Time to heal

  20 weeks

Secondary Outcomes (4)

• Complications

  20 weeks

• Advanced Wound Care Treatments

  20 weeks

• Cost

  20 weeks

• Healed Proportion

  20 weeks

Other Outcomes (3)

• Unhealed Proportion

  20 weeks

• PAR

  20 weeks

• AWC Failure

  20 weeks

Study Arms (2)

debritom+

EXPERIMENTAL

Group 1: Medaxis debritom+

Device: Study Device Debridement

Sharp Scalpel

ACTIVE COMPARATOR

Group 2: SOC (Sharp Scalpel Debridement)

Device: SOC Debridement

Interventions

Study Device Debridement DEVICE

debritom+ water jet debridement

debritom+

SOC Debridement DEVICE

Sharp Scalpel

Sharp Scalpel

Eligibility Criteria

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

You may qualify if:

• General
• Potential subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization:
• 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.
• DFU
• 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
• 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).
• The index ulcer has been offloaded for at least 14 days prior to randomization
• 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

You may not qualify if:

• 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.
• 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
• Traumatic
• 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)
• General
• Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization:
• 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.
• History of radiation at the wound site (regardless of time since last radiation treatment).
• 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).
• Subject has a previous diagnosis of HIV, Hepatitis C, or other contagious diseases.
• 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.

Sponsors & Collaborators

• Medaxis, LLC: lead
• NAMSA: collaborator

Study Sites (1)

MCR Health, Inc.

Bradenton, Florida, 34208, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Surgical Wound Dehiscence

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; Varicose Veins; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Melvin B Price, DPM

  MCR Health Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharona Segal-Leibovich

CONTACT

646-369-1570; ssegal-leibovich@namsa.com

Amy Jo Johnson

CONTACT

amyjo.johnson@medaxis.us

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT). Control and Treatment Arms

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 9, 2021
• Study Start: November 29, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)