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VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING 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
Observational

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
N/A
  • Male or Female - 18 years or older - Diabetic Foot Ulcer - Ambulatory in the home without the aid of another person - Able to provide written informed consent

Exclusion Criteria:

  • Wound present for more than one year -HbA1c > 12%
  • ABI of 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

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Study Stats
Protocol No.
24-6284
Category
Endocrine and Metabolic Disorders
Principal Investigator
Bijan Najafi
Contact
Alexis Noirot
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT06439667
For detailed technical eligibility, visit ClinicalTrials.gov.