Tele-Exercise Platform for Plantar Wound Healing

About

Brief Summary

The purpose of the study is design and use a telemedicine platform which integrates video-chat, pre-programmed interactive game-based foot, and ankle exercise modules, and real-time quantitative performance metrics displayed to the clinician to improve patient's perfusion to the lower extremity, improve diabetic wound healing and prevent muscle loss in the lower extremity.This is a cross sectional and comparative feasibility study. It is designed to explore acceptability, feasibility and proof of concept/ .

Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Observational

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Male or female adults (age 18 years and older)
  • Having Diabetic foot ulcer
  • Ambulatory (in the home without the aid of another person)
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Foot wound present for more than a year
  • HbA1c > 12%
  • ABI index limb is <0.60 and/or they are being considered for revascularization within the course of the study
  • Ulcer involving bone or tendon
  • Ulcer not caused by diabetes
  • Fully confined to a wheelchair
  • Any condition limiting the ability to engage in Tele-FootX exercise routine such as major cognitive decline, and major visual or hearing problem
  • Unable or unwilling to attend prescribed clinic visits
Study Stats
Protocol No.
24-6284
Category
Endocrine and Metabolic Disorders
Principal Investigator
Bijan Najafi
Contact
  • Steven Stokes
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT06439667
For detailed technical eligibility, visit ClinicalTrials.gov.