Exciflex Electroceutical Banadage for Chronic Wound Therapy
Recruiting now · Not applicable
Conditions studied: Chronic Wound, Diabetes, Spinal Cord Injury, Ischemic Wound
In brief
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.
Key facts
- Study ID
- NCT04887688
- Run by
- VA Office of Research and Development
- People needed
- 16
- Starts
- 2022-10-05
- Expected to finish
- 2029-09-30
- Last updated by the study team
- 2026-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include:
- Pregnancy
Where it is running
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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