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 measures design to assess t
| Condition(s) | Chronic Wound, Diabetes, Spinal Cord Injury, Ischemic Wound |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 criteri |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | VA Office of Research and Development |
| Locations | Cleveland, Ohio, United States |
| Start date | 2022-10-05 |
| NCT ID | NCT04887688 |
| Official listing | https://clinicaltrials.gov/study/NCT04887688 |