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NCT Number: NCT04887688

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 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.

Recruiting

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Key information

Conditions

Chronic Wound Central Nervous System Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Ischemic Wound Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location status: Recruiting

Location contact

Kath M. Bogie, PhD

PRINCIPAL_INVESTIGATOR

Katie R Schwartz, RN

CONTACT

[email protected]

216-791-3800 ext. 63802

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exciflex

Device

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

Primary outcomes

  1. Digital imaging

    Time frame: At each bandage change for up to 6 weeks

    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.

  2. IR imaging

    Time frame: At each bandage change for up to 6 weeks

    Wound bed temperature (degrees C)

  3. Laser Speckle imaging

    Time frame: At each bandage change for up to 6 weeks

    Wound region blood flow (blood perfusion using arbitrary units)

Secondary outcomes

  1. Wound swabs

    Time frame: At every bandage change for up to 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kath M Bogie, PhD

CONTACT

[email protected]

(204) 778-3083

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Toward Smart Personalized Electrotherapy for Enhanced Healing of Ischemic Wounds

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
May 14, 2021
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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