Exciflex Electroceutical Banadage for Chronic Wound Therapy
Purpose
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.
Conditions
- Chronic Wound
- Diabetes
- Spinal Cord Injury
- Ischemic Wound
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- At the baseline assessment, the wound dressing will be removed and wound status will be evaluated. Participants will then be randomly assigned to the intervention group (Group A) or control group (Group B). Progressive changes in wound size, indicative of wound healing, will be determined using 3D digital stereophotogrammetry (LifeViz 3D system, Quantificare Inc., San Mateo, CA) together with wound swabs to collect wound bed fluid. The study cohort will comprise Veterans with ischemic wounds.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group A: Wound treated using exciflex |
Intervention treated wounds in Group A participants will be covered using the exciflex bandage which will be activated to deliver ES using a 10% duty cycle, i.e. ES will be active for 1 minute out of every 10 minutes. ES will be delivered for up to 10 weeks or until the wound is healed for 3 days. The exciflex bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically multi-modal digital imaging and wound swabs. The exciflex power/control module will then be transferred to a new sterile flexible substrate and the exciflex bandage reapplied to the wound. |
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No Intervention Group B: Wound treated using standard of care |
Control treated wounds in Group B participants will be covered with an exciflex bandage that is not activated . The bandage will be used for up to 10 weeks or until the wound is healed for 3 days. The bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically multi-modal digital imaging and wound swabs . A fresh sterile inactive exciflex bandage will then be reapplied to the wound. |
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Recruiting Locations
Cleveland, Ohio 44106-1702
More Details
- Status
- Recruiting
- Sponsor
- VA Office of Research and Development
Detailed Description
The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of the exciflex bandage in clinical use. Non-invasive assessments will include multi-modal imaging using the Mimosa Pro imaging system, MolecuLight and wound swabs to collect wound bed fluid thus meeting the recommendations of Ramsay et al. for obtaining accurate, reliable standardized samples. Wound healing primary endpoints will follow Wound Care Collaborative Community guidance. The study cohort will comprise Veterans with chronic wounds. A parallel-group randomization will be used and participants will be randomly assigned to one of two groups: the experimental or investigation group (Group A) or the control group (Group B). Random allocation software will be used to produce qualified lists for parallel group assignment a priori and ensure that participants are randomized into groups that result in equal sample sizes Each will have a 50% chance of being assigned to either group. The two groups are Group A (exciflex treatment and monitoring) or Group B (sham treatment, i.e. exciflex monitoring without treatment activated)