Diabetic Foot UlcerEVIDENTNCT04920253
Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
A study testing Study Device Debridement and SOC Debridement in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Medaxis, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Venous Leg Ulcer, Surgical Wound Dehiscence
- What is being tested?
- Study Device Debridement and SOC Debridement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- All wounds using the CEAP VLU Classification, except for those in the exclusion criteria. (See Appendix A for definitions)
- 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
- All wounds using the Sandy Grading System, except those in the exclusion criteria. (See Appendix A for definitions)
- 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)
Who cannot join
- 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.
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- 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.
- Subject is pregnant or breast-feeding.
- Presence of diabetes with poor metabolic control as documented with an HbA1c >12.0 % within 90 days of randomization.
- Subject has end-stage renal disease as evidenced by a serum creatinine > 3.0mg/dL within 6 months of randomization.
- BMI >55
- PAR experiences a >30% change between SV1 and SV2 DFU
- Wagner 2 wounds that require debridement of bone.
- 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
- Exclude
- Secondary post thrombotic
- Venous Obstruction
- Venous Obstruction with reflux
- Lipodermato sclerosis or atrophic blanche
- 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
- 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
- Using CDC Surgical Wound Classification, exclude
- Class IV - dirty infected wounds
- SSI - Deep incisional and organ space
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amy Jo Johnson contact
United States1 site, 1 recruiting
- Recruiting
MCR Health, Inc.
Bradenton, Florida, 34208
Melvin B Price, DPM
About this study
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.
Read the 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.
- Being tested
- Study Device Debridement, SOC Debridement
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Device DebridementDevice
debritom+ water jet debridement
SOC DebridementDevice
Sharp Scalpel
| Study group | Role | What they receive |
|---|---|---|
| debritom+ | Experimental | Group 1: Medaxis debritom+ Receives: Device: Study Device Debridement |
| Sharp Scalpel | Active comparator | Group 2: SOC (Sharp Scalpel Debridement) Receives: Device: SOC Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
Time to heal
Measured: 20 weeks
Secondary outcomes (4)
Complications
Incidence of all index wound-related complications (eg. cellulitis or Infection), hospitalization, wound recurrence
Measured: 20 weeks
Advanced Wound Care Treatments
Number of successful advanced wound care treatments placed (eg. Negative Pressure Wound Therapy /grafts)
Measured: 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.
Measured: 20 weeks
Healed Proportion
Proportion of wounds completely healed
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start29 Nov 2021
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT). Control and Treatment Arms
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medaxis, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
- Investigators
- Melvin B Price, DPM, Principal investigator, MCR Health Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920253
- Sponsor's protocol ID
- MEDX-DT-03
- Acronym
- EVIDENT
- Status last verified
- Nov 2024
- First submitted
- 3 Jun 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
- ClinicalTrials.gov ID
- NCT04920253
- Acronym / sponsor ID
- EVIDENT / MEDX-DT-03
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Medaxis, LLCIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT). Control and Treatment Arms
| Arm | Type | Receives |
|---|---|---|
| debritom+ | Experimental | Device: Study Device DebridementGroup 1: Medaxis debritom+ |
| Sharp Scalpel | Active comparator | Device: SOC DebridementGroup 2: SOC (Sharp Scalpel Debridement) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Device Debridementdebritom+ water jet debridement | Device | debritom+ |
| SOC DebridementSharp Scalpel | Device | Sharp Scalpel |
Primary outcome
Wound Closure
Time frame: 20 weeks
Time to heal
4 secondary outcomes
Complications
Time frame: 20 weeks
Advanced Wound Care Treatments
Time frame: 20 weeks
Cost
Time frame: 20 weeks
Healed Proportion
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Jo Johnson contact
Melvin B Price, DPM principal investigator
MCR Health Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Device Debridement and SOC Debridement in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Medaxis, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharona Segal-Leibovich (646-369-1570, ssegal-leibovich@namsa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Closure (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.