Tele-Exercise Platform for Plantar Wound Healing

NCT06439667 | Enrolling By Invitation

• 2 other identifiers: IRB-24-62841R43AG082614-01
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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/ .

Conditions

Diabetic Foot Ulcer; Wound Healing; Wound Care

Keywords

Diabetic Foot Ulcer; Ambulatory in the home without the aid of another person; Able to provide written informed consent

Outcome Measures

Primary Outcomes (1)

• Tissue Oxygen Saturation (SatO2)

  For measuring tissue oxygen saturation (SatO₂), we will use a validated, non-invasive near-infrared (NIR) imaging device (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Canada). The device estimates SatO₂ levels in superficial tissue by tracing the wound perimeter in real-time. To minimize bias related to wound size and SatO₂ measurement, all wounds will be traced along their internal borders-excluding surrounding skin-using a standardized technique across all participants. Measurements will be conducted at baseline and at the end of the Tele-FootX session, which is expected to last approximately 15 minutes.

  baseline, 15 minutes

Secondary Outcomes (2)

• Muscle Activation

  15 minutes

• Percentage of successfully completed leg exercise tasks within a 10-Minute session

  10 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Convenient and selected based on available resources to demonstrate feasibility and the proof of concept effectiveness.

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• BioSensics: collaborator
• University of California, Los Angeles: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• Finco MG, Najafi B, Zhou H, Hamad A, Ibrahim R, Al-Ali F. Game-based intradialytic non-weight-bearing exercise training on gait speed and balance in older adults with diabetes: a single-blind randomized controlled trial. Sci Rep. 2023 Aug 30;13(1):14225. doi: 10.1038/s41598-023-41290-3.

  PMID: 37648695 BACKGROUND

• Lee M, Hamad A, Azarian M, Beom J, Ouattas A, Dehghan Rouzi M, Rodriguez N, Quach N, Ibrahim R, Mathew M, Talal T, Al-Ali F, Najafi B. Efficacy and Feasibility of Intradialytic Plantar Electrical Stimulation in Patients With Diabetes: A Randomized Double-Blind Controlled Trial. Diabetes Care. 2024 Dec 1;47(12):2205-2213. doi: 10.2337/dc24-0928.

  PMID: 39316389 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: December 15, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (1)