RECRUITING

Exciflex for Chronic Wound Therapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Toward Smart Personalized Electrotherapy for Enhanced Healing of Ischemic Wounds

Quick Facts

Study Start:2022-10-05
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04887688

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All participants with chronic ischemic wounds treated at LSCVAMC will be potentially eligible for the study
  2. * 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
  1. * Age less than 18 years.
  2. * Pregnancy

Contacts and Locations

Study Contact

Kath M Bogie, PhD
CONTACT
(204) 778-3083
Katherine.Bogie@va.gov

Principal Investigator

Kath M. Bogie, PhD
PRINCIPAL_INVESTIGATOR
Louis Stokes VA Medical Center, Cleveland, OH

Study Locations (Sites)

Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Kath M. Bogie, PhD, PRINCIPAL_INVESTIGATOR, Louis Stokes VA Medical Center, Cleveland, OH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-05
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2022-10-05
Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Wound
  • Diabetes
  • Spinal Cord Injury
  • Ischemic Wound