Recruiting

Exciflex Bandage

Sponsor:

VA Office of Research and Development

Code:

NCT04887688

Conditions

Chronic Wound

Diabetes

Spinal Cord Injury

Ischemic Wound

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

exciflex

Study Details

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 Louis Stokes Cleveland VA Medical Center (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.

Conditions

Chronic Wound

Diabetes

Spinal Cord Injury

Ischemic Wound

Study ID

NCT04887688

Start date

Oct 5, 2022

Status verified date

Aug, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Jul 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All participants with chronic 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:

  • Pregnancy

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A: Wound treated using exciflex

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 multi-modal digital imaging and wound swabs. The exciflex power/control module will then be transferred to a new sterile flexible substrate and the exciflex bandage reapplied to the wound.

no intervention: Group B: Wound treated using standard of care

Control treated wounds in Group B participants will be covered with an exciflex bandage that is not activated . The bandage will be used for up to 10 weeks or until the wound is healed for 3 days. The 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 multi-modal digital imaging and wound swabs . A fresh sterile inactive exciflex bandage will then be reapplied to the wound.

Interventions

exciflex

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

Primary outcome measure

  • Digital imaging [ Time Frame: At each bandage change for up to 6 weeks ]
  • IR imaging [ Time Frame: At each bandage change for up to 6 weeks ]
  • Laser Speckle imaging [ Time Frame: At each bandage change for up to 6 weeks ]

Central Contacts and Locations

Central contacts

Kath M Bogie, PhD

(204) 778-3083Katherine.Bogie@va.gov

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Recruiting

Cleveland, Ohio, United States, 44106-1702

Contacts

Katie R Schwartz, RN

(216) 791-3800Katelyn.Schwartz@va.gov

Principal Investigator:

Kath M. Bogie, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-10.