Exciflex for Chronic Wound Therapy

NCT04887688 | Recruiting

• 1 other identifier: F2166-R
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Wound; Diabetes; Spinal Cord Injury; Ischemic Wound

Outcome Measures

Primary Outcomes (3)

• 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

• IR imaging

  Wound bed temperature (degrees C)

  At each bandage change for up to 6 weeks

• Laser Speckle imaging

  Wound region blood flow (blood perfusion using arbitrary units)

  At each bandage change for up to 6 weeks

Secondary Outcomes (1)

• Wound swabs

  At every bandage change for up to 6 weeks

Study Arms (2)

Group A: Wound treated using exciflex

EXPERIMENTAL

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 a 3D digital image and wound swabs will be obtained. The exciflex power/control module will then be transferred to a new sterile flexible substrate and the exciflex bandage reapplied to the wound.

Device: exciflex

Group B: Wound treated using standard of care

NO INTERVENTION

Control treated wounds in Group B participants will be covered with a standard of care hydrogel dressing such as Restore (Hollister Inc) together with Tegaderm . The SoC dressing will be used for up to 10 weeks or until the wound is healed for 3 days. The SoC 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 a 3D digital image and wound swabs will be obtained. A fresh sterile SoC bandage will then be reapplied to the wound.

Interventions

exciflex DEVICE

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

Group A: Wound treated using exciflex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age less than 18 years.
• Pregnancy

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kath M. Bogie, PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kath M Bogie, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: May 14, 2021
• Study Start: October 5, 2022
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)