Exciflex for Chronic Wound Therapy

NCT ID: NCT04887688

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2029-09-30

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.

Conditions

Chronic Wound; Diabetes; Spinal Cord Injury; Ischemic Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 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.

Group Type: EXPERIMENTAL

exciflex

Intervention Type: DEVICE

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

Group B: Wound treated using standard of care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

exciflex

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

Intervention Type: 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

• Age less than 18 years.
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kath M. Bogie, PhD

Role: PRINCIPAL_INVESTIGATOR

Louis Stokes VA Medical Center, Cleveland, OH

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kath M Bogie, PhD

Role: CONTACT

Katherine.Bogie@va.gov

(204) 778-3083

Facility Contacts

Katie R Schwartz, RN

Role: primary

Katelyn.Schwartz@va.gov

216-791-3800 ext. 63802

Other Identifiers

F2166-R

Identifier Type: -

Identifier Source: org_study_id