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Exciflex for Chronic Wound Therapy
NCT04887688 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE exciflex
Study Locations (1)
Ohio
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-10-05 |
| Est. Completion | 2029-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04887688
The ClinicalTrials.gov registry entry for NCT04887688 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Diabetes appearing as the primary indexed condition, and to 1 intervention — of which exciflex is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04887688 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04887688 about?
NCT04887688 is a clinical study titled "Exciflex for Chronic Wound Therapy". 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 measur...
What is the current status of trial NCT04887688?
This trial is currently recruiting. It is a NA study. The enrollment target is 16 participants. The study started on 2022-10-05. Estimated completion is 2029-09-30.
What conditions does trial NCT04887688 study?
This clinical trial studies the following conditions: Diabetes, Spinal Cord Injury, Chronic Wound, Ischemic Wound. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04887688?
The interventions under investigation include: exciflex (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04887688?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04887688 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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