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Electrotherapy Device
Exciflex Bandage for Chronic Wounds
N/A
Recruiting
Led By Kath M. Bogie, PhD
Research Sponsored by VA Office of Research and Development
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 at each bandage change for up to 6 weeks
Awards & highlights
Study Summary
This trial is testing whether the exciflex bandage is more effective than the standard of care for ischemic wounds in Veterans. The study will use a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use.
Who is the study for?
This trial is for Veterans with chronic ischemic wounds, particularly those with spinal cord injuries or diabetes. Participants must be treated at LSCDVAMC and can be inpatients or residents of Long-Term Care Unit, or followed by Podiatry Service for wound care. It's not open to individuals under 18 years old or pregnant women.Check my eligibility
What is being tested?
The trial is testing the exciflex bandage against standard care for treating ischemic wounds. Exciflex delivers electrotherapy automatically and could improve healing while reducing costs. The study uses a randomized design to compare outcomes between treatments.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include skin irritation, discomfort from the bandage, or reactions to electrotherapy. As this is a pilot assessment, part of the study will likely monitor and document any adverse effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at each bandage change for up to 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at each bandage change for up to 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Digital imaging
IR imaging
Laser Speckle imaging
Secondary outcome measures
Wound swabs
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group A: Wound treated using exciflexExperimental Treatment1 Intervention
Intervention treated wounds in Group A participants will be covered using the exciflex bandage which will be activated to deliver ES using a 10% duty cycle, i.e. ES will be active for 1 minute out of every 10 minutes. ES will be delivered for up to 10 weeks or until the wound is healed for 3 days. The exciflex bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically a 3D digital image and wound swabs will be obtained. The exciflex power/control module will then be transferred to a new sterile flexible substrate and the exciflex bandage reapplied to the wound.
Group II: Group B: Wound treated using standard of careActive Control1 Intervention
Control treated wounds in Group B participants will be covered with a standard of care hydrogel dressing such as Restore (Hollister Inc) together with Tegaderm . The SoC dressing will be used for up to 10 weeks or until the wound is healed for 3 days. The SoC bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically a 3D digital image and wound swabs will be obtained. A fresh sterile SoC bandage will then be reapplied to the wound.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,268 Total Patients Enrolled
Kath M. Bogie, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH
3 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People with long-term wounds caused by reduced blood flow who are treated at LSCVAMC may be able to join the study.I am a Veteran with spinal cord injury or diabetes receiving care for wounds.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Group B: Wound treated using standard of care
- Group 2: Group A: Wound treated using exciflex
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.
Are there any slots available for enrolment in this scientific trial?
"As seen on clinicaltrials.gov, this medical trial is still recruiting participants after being posted and last modified in October of 2022."
Answered by AI
What is the current enrollment limit for this clinical experiment?
"Confirmed. According to the clinicaltrials.gov database, this research has been open since October 5th 2022 and is seeking 16 participants from only one medical facility."
Answered by AI
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