Exciflex Electroceutical Banadage for Chronic Wound Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
Objectives: The study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (SoC) for ischemic wounds and will involve participants who are Veterans with lower extremity ischemic wounds.
Research Plan: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use.
Methodology: All participants with chronic ischemic wounds treated at Louis Stokes Cleveland VA Medical Center (LSCDVAMC) will be potentially eligible for the study. Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care. In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include; (1) Age less than 18 years and (2) Pregnancy.
Clinical Significance: Chronic ischemic wounds fail to heal normally and are a major challenge in the long-term care of many Veterans. The exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up to seven days, unless indicated. The overall study goal is to complete pre-market testing and evaluation of the exciflex bandage system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All participants with chronic wounds treated at LSCVAMC will be potentially eligible for the study
Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long-Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care
Disqualifiers
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
exciflex
Deviceuntethered electronic bandage with all the components of a surface stimulation system mounted on a flexible substrate.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Group A: Wound treated using exciflexExperimental treatment 1 intervention
Group B: Group B: Wound treated using standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Digital imaging
Quantify wound size (mm2 for surface area, mmm3 for volume). The outcomes measures of wound surface area \& wound volume are done by the investigators' 3D wound imaging camera that produces a digital output which includes both wound surface area (SA) \& wound volume. One is derived from the other, i.e. Wound volume = SA x average depth.
Time frame
At each bandage change for up to 6 weeks2
IR imaging
Wound bed temperature (degrees C)
Time frame
At each bandage change for up to 6 weeks3
Laser Speckle imaging
Wound region blood flow (blood perfusion using arbitrary units)
Time frame
At each bandage change for up to 6 weeksSecondary outcomes
1
Wound swabs
Further analysis using real-time polymerase chain reaction (PCR) for assessment of wound infection and healing biomarkers, including but not limited to VEGF and TNF-alpha. rt-PCR is a single assessment process to measure multiple biomarkers of wound infection and healing from a single sample, using plates that contain up to 96 different biomarkers each.
Time frame
At every bandage change for up to 6 weeksSponsors and contacts
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Source ClinicalTrials.gov