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Procedure
Study Device Debridement for Wound Care (EVIDENT Trial)
N/A
Recruiting
Led By Melvin B Price, DPM
Research Sponsored by Medaxis, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights
EVIDENT Trial Summary
This trial will compare the rate and frequency of wound healing, and associated financial savings, when using Medaxis debritom+ versus standard of care as a choice of debridement method.
Eligible Conditions
- Traumatic Wounds
- Foot Ulcer
- Surgical Wound Separation
- Venous Leg Ulcer
EVIDENT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Wound Closure
Secondary outcome measures
Advanced Wound Care Treatments
Complications
Cost
+1 moreOther outcome measures
AWC Failure
PAR
Unhealed Proportion
EVIDENT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: debritom+Experimental Treatment1 Intervention
Group 1: Medaxis debritom+
Group II: Sharp ScalpelActive Control1 Intervention
Group 2: SOC (Sharp Scalpel Debridement)
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Who is running the clinical trial?
Medaxis, LLCLead Sponsor
1 Previous Clinical Trials
220 Total Patients Enrolled
NAMSAOTHER
45 Previous Clinical Trials
16,743 Total Patients Enrolled
Melvin B Price, DPMPrincipal InvestigatorMCR Health Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had radiation treatment at the area where the wound is located.You weigh more than 55 pounds for every 4 feet of your height.You have been diagnosed with HIV, Hepatitis C, or other contagious diseases in the past.Your diabetes is not well controlled, as shown by a high HbA1c level.You have deep wounds that need to have bone removed.You have a bone infection in your foot confirmed by recent x-ray, CAT scan, or MRI.History of blood clotting issues after an initial blood clot.You have a blockage in your veins.You have a blockage in your veins with backward flow of blood.You have lipodermatosclerosis or atrophic blanche.If your surgical wound is classified as Grade 3 in the Sandy Grading System, with organs exposed, or Grade 3a with severe infection as determined by the study doctor, you cannot participate.The wound looks like it could be cancerous or has been diagnosed as cancer.You have used certain medications that weaken the immune system or kill fast-growing cells within the past two weeks or may need to use them during the study.You are currently taking a medication called Celecoxib for any reason.Your kidney function is severely impaired, as shown by a high level of creatinine in your blood.Criterion: The size of the wound changes by more than 30% between the first and second visits.You have a bone infection in the leg that needs treatment, as confirmed by recent x-ray, CAT Scan, or MRI.The wound being studied should be between 1 square centimeter and 25 square centimeters in size.You have a foot sore related to diabetes that fits certain criteria.Your foot has good blood flow, as shown by specific tests done within 3 months before the study.You have wounds classified as CEAP VLU, unless they are listed in the exclusion criteria.You have wounds that are graded using the Sandy Grading System, unless they are listed in the exclusion criteria.You have wounds that are not heavily infected, such as deep incisions or organ space infections.
Research Study Groups:
This trial has the following groups:- Group 1: debritom+
- Group 2: Sharp Scalpel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the capacity for this research project with regards to participants?
"Affirmative. According to the information provided on clinicaltrials.gov, this medical experiment has been open for recruitment since November 29th 2021 and was recently revised on December 15th 2021. The research project is aiming to recruit 180 individuals at a single site of study."
Answered by AI
Is this experiment actively seeking participants?
"According to the latest findings on clinicaltrials.gov, this clinical trial is currently in its recruitment process which was initiated on November 29th 2021 and updated most recently on December 15th 2021."
Answered by AI
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