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A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot
NCT04564443 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this clinical investigation is to assess performance of the Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.
Conditions Studied
Interventions
- OTHER Medaxis Debritom+
- OTHER Sharp Surgical Debridement
- OTHER Additional Outer Dressing Application
- OTHER Offloading
- OTHER Fibracol Wound Dressing
Study Locations (6)
California
- CCR Research — San Francisco
Florida
- Doctors Research Network — South Miami
Maryland
- Foot and Ankle Associates of the Mid-Atlantic — Frederick
North Carolina
- Foot and Ankle Associates of the Mid-Atlantic — Raleigh
Ohio
- Lower Extremity Institute for Research and Therapy, LLC — Youngstown
Virginia
- Foot and Ankle Associates of the Mid-Atlantic — Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2020-09-11 |
| Est. Completion | 2024-12-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04564443
The ClinicalTrials.gov registry entry for NCT04564443 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medaxis, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 5 interventions — of which Medaxis Debritom+ is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04564443 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04564443 about?
NCT04564443 is a clinical study titled "A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot". The purpose of this clinical investigation is to assess performance of the Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.
What is the current status of trial NCT04564443?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 222 participants. The study started on 2020-09-11. Estimated completion is 2024-12-30.
What conditions does trial NCT04564443 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer, Diabetic Foot. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04564443?
The interventions under investigation include: Medaxis Debritom+ (OTHER), Sharp Surgical Debridement (OTHER), Additional Outer Dressing Application (OTHER), Offloading (OTHER), Fibracol Wound Dressing (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04564443?
This trial is sponsored by Medaxis, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04564443 being conducted?
This trial has 6 study locations across California, Florida, Maryland, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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