Exciflex for Chronic Wound Therapy

Diabetes Clinical Trial

Official title:

Toward Smart Personalized Electrotherapy for Enhanced Healing of Ischemic Wounds

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04887688
• Other study ID #: F2166-R
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: September 30, 2027

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: Kath M Bogie, PhD
• Phone: (204) 778-3083
• Email: Katherine.Bogie[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: September 30, 2027
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Wound
• Diabetes
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• exciflex
untethered electronic bandage with all the components of a surface stimulation system mounted on a flexible substrate.

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Digital imaging	Quantify wound size (mm2 for surface area, mmm3 for volume). The outcomes measures of wound surface area & wound volume are done by the investigators' 3D wound imaging camera that produces a digital output which includes both wound surface area (SA) & wound volume. One is derived from the other, i.e. Wound volume = SA x average depth.	At each bandage change for up to 6 weeks
Primary	IR imaging	Wound bed temperature (degrees C)	At each bandage change for up to 6 weeks
Primary	Laser Speckle imaging	Wound region blood flow (blood perfusion using arbitrary units)	At each bandage change for up to 6 weeks
Secondary	Wound swabs	Further analysis using real-time polymerase chain reaction (PCR) for assessment of wound infection and healing biomarkers, including but not limited to VEGF and TNF-alpha. rt-PCR is a single assessment process to measure multiple biomarkers of wound infection and healing from a single sample, using plates that contain up to 96 different biomarkers each.	At every bandage change for up to 6 weeks