VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING

Diabetic Foot Ulcer Clinical Trial

— Tele-foot X  

Official title:

VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06439667
• Other study ID #: H-52991
• Status: Not yet recruiting
• Start date: September 3, 2024
• Est. completion date: January 3, 2028

Study information

• Verified date: May 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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/ .

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, we 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: January 3, 2028
• Est. primary completion date: January 3, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	BioSensics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Design interactive game-based platform	We will design an interactive game-based exercise platform using foot-mounted sensors and make it suitable for people with DFU by including game-based exercises inspired by the Buerger-Allen exercise program	4 weeks
Secondary	This study is designed to explore acceptability, feasibility safety, and proof of concept effectiveness of the Tele-FootX.	We will demonstrate the acceptability, feasibility, safety, and proof of concept effectiveness of the Tele-FootX in improving lower extremity perfusion by recruiting 15 participants with DFU. We will examine the perceived benefit, ease of use, technology acceptance, usability, and technology anxiety from the point of view of the 15 participants with DFU recruited in Aim 2, as well as 10 health care professionals with expertise in DFU management. To evaluate user experience, we interviewed participants to describe their experience using the sensor-based exergame technology with an adapted questionnaire called Technology Acceptance Model (TAM). Each TAM item will be graded using a 5-point Likert response question.	4 weeks