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New treatment option for Diabetic Foot Ulcer
Official title Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
ClinicalTrials.gov ID: NCT04920253
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General Potential people 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...
- 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.
You likely can't join if
- . (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...
- 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...
- 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...
- The index wound, in the opinion of the investigator, is suspicious for cancer or have a positive carcinoma diagnosis.
See the full eligibility criteria
Who can join
- General Potential people 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...
- 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...
- 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...
- All wounds using the CEAP VLU Classification, except for those in the
What rules you out
- . (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...
- 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...
- 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) Exclusion Criteria: General...
- 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...
- 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.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bradenton, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bradenton, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.