Diabetes Clinical Trial
Official title:
Toward Smart Personalized Electrotherapy for Enhanced Healing of Ischemic Wounds
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 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.
Status | Recruiting |
Enrollment | 16 |
Est. completion date | September 30, 2027 |
Est. primary completion date | October 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All participants with chronic ischemic 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 Exclusion Criteria: In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include: - Age less than 18 years. - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At each bandage change for up to 6 weeks | |
Primary | IR imaging | Wound bed temperature (degrees C) | At each bandage change for up to 6 weeks | |
Primary | Laser Speckle imaging | Wound region blood flow (blood perfusion using arbitrary units) | At each bandage change for up to 6 weeks | |
Secondary | 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. | At every bandage change for up to 6 weeks |
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