Status:

RECRUITING

Exciflex for Chronic Wound Therapy

Lead Sponsor:

VA Office of Research and Development

Conditions:

Chronic Wound

Diabetes

Eligibility:

All Genders

18+ years

Phase:

NA

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...

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 heal...

Eligibility Criteria

Inclusion

  • 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

  • In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include:
  • Age less than 18 years.
  • Pregnancy

Key Trial Info

Start Date :

October 5 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2029

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT04887688

Start Date

October 5 2022

End Date

September 30 2029

Last Update

September 11 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States, 44106-1702