Diabetic Foot UlcerTele-FootXNCT06439667
Tele-Exercise Platform for Plantar Wound Healing
An observational study of Diabetic Foot Ulcer and Wound Healing, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer, Wound Healing, Wound Care
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 15 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Convenient and selected based on available resources to demonstrate feasibility and the proof of concept effectiveness.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Virtually Supervised Tele-Exercise Platform for Accelerating Plantar Wound Healing
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/ .
Read the 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.
- 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
- Medical subject headings
- Diabetic Foot
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 15 minutes
Secondary outcomes (2)
Muscle Activation
To assess muscle activation and fatigue in response to each exercise program, surface electromyography (sEMG) sensors will be placed on the tibialis anterior and gastrocnemius muscles. Muscle fatigue will be evaluated by analyzing the power spectrum of sEMG signals using the Welch Periodogram. Measurements will be taken during the first and last minutes of the continuous, interactive Tele-FootX session. Mean frequencies and amplitudes will be compared between these intervals to assess fatigue. We anticipate no significant change in amplitude or frequency, indicating minimal to no muscle fatigue.
Measured: 15 minutes
Percentage of successfully completed leg exercise tasks within a 10-Minute session
Feasibility will be assessed by evaluating participants' ability to complete all prescribed exercise tasks as guided by the Tele-FootX and Buerger-Allen exercise programs, each designed to be completed within a 10-minute session. Feasibility will be quantified as the percentage of successfully completed tasks, defined as exercises performed with sufficient angular velocity or range of motion, based on predefined thresholds. This percentage is calculated by dividing the number of successfully completed tasks by the total number of prescribed tasks within the session.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start15 Dec 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- BioSensics, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Bijan Najafi, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439667
- Sponsor's protocol ID
- IRB-24-6284
- Other IDs
- 1R43AG082614-01
- Acronym
- Tele-FootX
- Status last verified
- Mar 2026
- First submitted
- 28 May 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is an NIH SBIR study with a subaward from BioSensics. According to the contract agreement, any sharing of individual-level data may require prior approval from BioSensics, particularly if the data is intended for commercial or for-profit use.
Publications
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.
PubMed 37648695Lee 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.
PubMed 39316389
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtually Supervised Tele-Exercise Platform for Accelerating Plantar Wound Healing
- ClinicalTrials.gov ID
- NCT06439667
- Acronym / sponsor ID
- Tele-FootX / IRB-24-6284
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- BioSensics, National Institute on Aging (NIA)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Convenient and selected based on available resources to demonstrate feasibility and the proof of concept effectiveness.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tissue Oxygen Saturation (SatO2)
Time frame: baseline, 15 minutes
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.
2 secondary outcomes
Muscle Activation
Time frame: 15 minutes
Percentage of successfully completed leg exercise tasks within a 10-Minute session
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 37648695Finco 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.
- Background: PubMed 39316389Lee 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.
- Individual participant dataSharing planned: Undecided. This is an NIH SBIR study with a subaward from BioSensics. According to the contract agreement, any sharing of individual-level data may require prior approval from BioSensics, particularly if the data is intended for commercial or for-profit use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer and Wound Healing, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue Oxygen Saturation (SatO2) (time frame: baseline, 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06439667, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.