Exciflex Electroceutical Banadage for Chronic Wound Therapy
Toward Smart Personalized Electrotherapy for Enhanced Healing of Chronic Wounds
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include: * Pregnancy
About the study
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.
What is being tested
- exciflex (device)
Sponsor: VA Office of Research and Development · Participants: 16 · Started: Oct 5, 2022
Contact the study team
- Kath M Bogie, PhD · Phone: (204) 778-3083
Official record on ClinicalTrials.gov — NCT04887688
Locations in the U.S.
| Ohio | Louis Stokes VA Medical Center, Cleveland, OH, Cleveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.