Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Amputation
  • Open Wound
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This study is designed as a pilot study where 30 patients receiving a below the knee amputation with at least one open wound on the limb will be enrolled. Patients are identified through medical records. The patients will be selected based on inclusion and exclusion criteria through pre-screening th...

This study is designed as a pilot study where 30 patients receiving a below the knee amputation with at least one open wound on the limb will be enrolled. Patients are identified through medical records. The patients will be selected based on inclusion and exclusion criteria through pre-screening through the Comprehensive Wound Center's Limb Preservation Program and wound physicians/providers at Indiana University. The decision of amputation is made independently of the study and is solely made by the patient and their physician/provider. The provider decides based on the severity of the limb's condition if/when the limb should be amputated and will schedule this surgery with the patient based on current clinical standard of care. Study participation is decided independent of clinical decision. Patients enrolled in the study will wear the Patterned Electric Dressing (PED) on the wound(s) for up to 3 weeks or until amputation, whichever comes first and will have up to a total of 4 study visits.

Tracking Information

NCT #
NCT04018469
Collaborators
Not Provided
Investigators
Principal Investigator: Gordillo Gayle, MD Indiana University