Clinical trial NCT04887688: Exciflex for Chronic Wound Therapy
Official title: Toward Smart Personalized Electrotherapy for Enhanced Healing of Ischemic Wounds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Wound
Diabetes
Spinal Cord Injury
Ischemic Wound
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-05-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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 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.

Detailed description: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of the exciflex bandage in clinical use. 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.

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. Group A will include eight (8) participants using the study device. Group B will include eight (8) participants undergoing standard of care treatment (SoC) with no study device.

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

Primary outcomes:
measure: Digital imaging
timeFrame: At each bandage change for up to 6 weeks
measure: IR imaging
timeFrame: At each bandage change for up to 6 weeks
measure: Laser Speckle imaging
timeFrame: At each bandage change for up to 6 weeks
Secondary outcomes:
measure: Wound swabs
timeFrame: At every bandage change for up to 6 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
name: Kath M. Bogie, PhD
role: PRINCIPAL_INVESTIGATOR
References: