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Electroceutical Dressing Technology
Electroceutical Dressing Technology-EDThi for Wound Healing (EDT BioFilm Trial)
N/A
Waitlist Available
Led By Sashwati Roy, PhD
Research Sponsored by Indiana University
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 6 weeks
Awards & highlights
EDT BioFilm Trial Summary
This trial is testing a new type of dressing to see if it is effective in managing wound biofilm infection and healing the wound.
Eligible Conditions
- Wound Healing
EDT BioFilm Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response to the use of EDT treatment in prevention of wound biofilm infection
Secondary outcome measures
Percent of patients with response to EDT treatment on week 6 as compared to SoC only group
rate of wound closure 6 weeks post-treatment as compared to baseline
wound microbiome in SoC and SoC+ EDT treatment.
EDT BioFilm Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SOC and PED-10 +ProcelleraExperimental Treatment2 Interventions
In group 2, in addition to SoC, the patients will apply the EDThi dressing (PED-10) on the wound(s) for the first 3 weeks following enrollment followed by Procellera® or EDTlo for additional 3 weeks. The use of dressings will be discontinued anytime if complete wound closure is achieved.
Group II: Standard of Care OnlyActive Control1 Intervention
This will be group 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electroceutical Dressing Technology-EDThi
2021
N/A
~120
Adding EDTlo (Procellera®) for 3 weeks after use of EDThi
2021
N/A
~120
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
979 Previous Clinical Trials
982,904 Total Patients Enrolled
4 Trials studying Wound Healing
314 Patients Enrolled for Wound Healing
United States Department of DefenseFED
859 Previous Clinical Trials
225,386 Total Patients Enrolled
1 Trials studying Wound Healing
100 Patients Enrolled for Wound Healing
Naval Medical Research CenterFED
33 Previous Clinical Trials
2,788 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction or are allergic to zinc or silver.You have ongoing infections in wounds that haven't healed properly.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Only
- Group 2: SOC and PED-10 +Procellera
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.
How many people are currently enrolled in this research project?
"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical study, which was first advertised on June 3rd 2021, is currently seeking participants. Approximately 112 people must be enlisted from 3 distinct healthcare sites."
Answered by AI
Is this research endeavor still open for recruitment?
"Affirmative. Clinicaltrials.gov corroborates that this experiment, first announced on June 3rd 2021, is still recruiting participants for the study. Specifically, it seeks 112 individuals from 3 distinct sites to join the trial."
Answered by AI
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