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Procedure

Micro Water Jet Debridement for Diabetic Foot Ulcers

N/A
Recruiting
Led By Robert Galiano, MD
Research Sponsored by Medaxis, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 50% below the medial aspect of the malleolus
Without abscess or osteomyelitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial is testing a new type of medical treatment for people with diabetes who have foot ulcers.

Who is the study for?
This trial is for adults with diabetic foot ulcers that are not suspected to be cancerous, have no severe infections like abscess or osteomyelitis, and show adequate blood flow to the affected area. Participants must commit to weekly visits and use contraception if applicable. Those with certain medical conditions or poor diabetes control (HbA1c > 12.0) cannot join.Check my eligibility
What is being tested?
The study compares a new device called Medaxis Debritom+™ against standard sharp surgical debridement in treating diabetic foot ulcers. It aims to see which method is more effective by monitoring patient outcomes over time while using specific wound dressings.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, infection risks due to open wounds, possible bleeding during debridement procedures, and skin irritation from dressings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My injury is located lower than the middle of my ankle.
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I do not have an abscess or bone infection.
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I have a diabetic foot ulcer that fits certain size, location, and duration criteria.
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I am 18 years old or older.
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My affected foot has good blood flow.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of wounds completely healed at or before 16 weeks
Secondary outcome measures
Cost of hospitalization for any index wound-related event, including any wound recurrence involving the area of the index wound by 16 weeks
Cost of treatment, including any index wound-related complications, by 16 weeks
Incidence of any index wound-related cellulitis or infection by 16 weeks
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: (Medaxis Debritom+™) micro fluid jet wound therapyExperimental Treatment4 Interventions
Medaxis Debritom+™ is a high-quality, micro fluid jet therapy device designed to remove fibrin, necrotic tissue, and biofilm from wound surfaces by mechanical cleaning and stimulation of the diabetic foot wound
Group II: Sharp Surgical DebridementActive Control4 Interventions
Use of a surgical scalpel or curette to remove fibrin, necrotic tissue and biofilm from wound surfaces by mechanically cleaning the wound

Find a Location

Who is running the clinical trial?

Medaxis, LLCLead Sponsor
1 Previous Clinical Trials
180 Total Patients Enrolled
1 Trials studying Diabetic Foot
180 Patients Enrolled for Diabetic Foot
Professional Education and Research InstituteOTHER
13 Previous Clinical Trials
848 Total Patients Enrolled
12 Trials studying Diabetic Foot
819 Patients Enrolled for Diabetic Foot
Robert Galiano, MDPrincipal InvestigatorNorthwestern University School of Medicine
4 Previous Clinical Trials
260 Total Patients Enrolled
1 Trials studying Diabetic Foot
100 Patients Enrolled for Diabetic Foot

Media Library

Medaxis Debritom+ (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04564443 — N/A
Diabetic Foot Research Study Groups: (Medaxis Debritom+™) micro fluid jet wound therapy, Sharp Surgical Debridement
Diabetic Foot Clinical Trial 2023: Medaxis Debritom+ Highlights & Side Effects. Trial Name: NCT04564443 — N/A
Medaxis Debritom+ (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04564443 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
Foot and Ankle Associates of the Mid-Atlantic
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot
2020. "A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04564443.
~48 spots leftby Apr 2025
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