Exciflex for Chronic Wound Therapy
Chronic Wound, Diabetes, Spinal Cord Injury
About this trial
This is an interventional treatment trial for Chronic Wound
Eligibility Criteria
Inclusion Criteria:
- All participants with chronic ischemic 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:
- Age less than 18 years.
- Pregnancy
Sites / Locations
- Louis Stokes VA Medical Center, Cleveland, OHRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Group A: Wound treated using exciflex
Group B: Wound treated using standard of care
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 a 3D digital image and wound swabs will be obtained. The exciflex power/control module will then be transferred to a new sterile flexible substrate and the exciflex bandage reapplied to the wound.
Control treated wounds in Group B participants will be covered with a standard of care hydrogel dressing such as Restore (Hollister Inc) together with Tegaderm . The SoC dressing will be used for up to 10 weeks or until the wound is healed for 3 days. The SoC 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 a 3D digital image and wound swabs will be obtained. A fresh sterile SoC bandage will then be reapplied to the wound.