Clinical trial NCT06439667: Tele-Exercise Platform for Plantar Wound Healing
Official title: Virtually Supervised Tele-Exercise Platform for Accelerating Plantar Wound Healing
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: BioSensics
First posted: 2024-06-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenient and selected based on available resources to demonstrate feasibility and the proof of concept effectiveness.

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/ .

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tissue Oxygen Saturation (SatO2)
timeFrame: baseline, 15 minutes
Secondary outcomes:
measure: Muscle Activation
timeFrame: 15 minutes
measure: Percentage of successfully completed leg exercise tasks within a 10-Minute session
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University California, Los Angeles
state: California
Study officials:
References:
citation: 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.
citation: 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.