Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Bijan Najafi, PhD
Headshot of Bijan Najafi
Bijan Najafi

Description

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/ .

Official Title

Virtually Supervised Tele-Exercise Platform for Accelerating Plantar Wound Healing

Details

Foot ulceration is the most common and costly late complication of diabetes, with morbidity and mortality being worse than many cancers. It is estimated that up to one-third of people with diabetes will develop a diabetic foot ulcer (DFU) in their lifetime. Non-healing DFUs are a leading cause of hospitalization, amputation, disability, and death among people with diabetes. In the United States, one-third of all diabetes-related costs are spent on diabetic foot care, with two-thirds of the costs incurred in inpatient settings, constituting a substantial economic burden to society. Therefore, every means possible should be used to try to heal DFU and prevent amputation. In this regard, there is a significant body of evidence related to the clinical benefits of exercise for people with DFU, including improving blood flow and oxygen supply, muscle loss prevention, and joint mobility. Despite this evidence, exercise is not part of the standard care for wound healing, mainly because there is no solution for promoting and managing home-based exercise programs for people with DFU.

To address the gaps described above, the investigators propose an interactive foot and ankle tele-exercise platform called "Tele-FootX". This platform allows clinicians to remotely and virtually supervise exercise tasks and coach patients to perform evidence-based foot and ankle exercises inspired by the validated Buerger-Allen (BA), while also educating and monitoring the patients adherence to the exercise program.

Keywords

Diabetic Foot Ulcer, Wound Healing, Wound Care, Ambulatory in the home without the aid of another person, Able to provide written informed consent, Diabetic Foot, Foot Ulcer, Wounds and Injuries

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • University California, Los Angeles
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Bijan Najafi, PhD
    As an accomplished professional specializing in digital health, I devote my efforts towards improving healthcare equity via decentralized models.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
Links
Sign up for this study
ID
NCT06439667
Study Type
Observational
Participants
Expecting 15 study participants
Last Updated