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NCT04887688 · ClinicalTrials.gov registry record · NA
Exciflex for Chronic Wound Therapy
A NA study of Diabetes and Spinal Cord Injury, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT04887688 is a NA study of Diabetes and Spinal Cord Injury that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 16 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04887688, a NA study of Diabetes and Spinal Cord Injury, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
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.
NCT04887688 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
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.
What interventions are being tested in trial NCT04887688?
The interventions under investigation include: exciflex (DEVICE).
Who is sponsoring clinical trial NCT04887688?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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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Related
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