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Tele-FootX: Virtually Supervised Tele-Exercise Platform for Accelerating Plantar Wound Healing

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AG082614-01
Agency Tracking Number: R43AG082614
Amount: $275,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PA22-177
Timeline
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-04-15
Award End Date (Contract End Date): 2024-03-31
Small Business Information
57 Chapel St, Suite 200
Newton, MA 02458-1080
United States
DUNS: 802270988
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ASHKAN VAZIRI
 (888) 589-6213
 ashkan.vaziri@biosensics.com
Business Contact
 ASHKAN VAZIRI
Phone: (888) 589-6213
Email: ashkan.vaziri@biosensics.com
Research Institution
N/A
Abstract

Abstract
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 as there is no solution for promoting
and managing home-based exercise programs for people with DFU.
In this Phase I SBIR project, we will design an interactive foot and ankle exercise program for people with DFU
using wearable sensors called Tele-FootX™. Tele-FootX will enable both remotely and virtually supervised
evidence-based foot and ankle exercises and allow clinicians to educate, monitor, and coach patients. The
gaming features of the platform will promote adherence to the prescribed exercise programs, and, subsequently,
wound healing. This approach is supported by our proof-of-concept study, where we demonstrated the benefit
of interactive foot and ankle exercises to improve lower extremity perfusion and increase activity in the calf
muscle. To achieve this goal, in Aim 1, 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. In Aim 2, 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.
In Phase II, we will introduce new gaming features to improve engagement, as well as features for clinicians to
educate, manage and personalize the home-based exercise program for each patient. We will also integrate the
proposed solution into existing hospital records and remote assessments (e.g., EPIC). We will validate the final
product in a 12-week randomized control trial. There are existing CPT codes that cover tele-exercise programs.
The existence of reimbursement codes (CPT codes 98975, 98977, 98980, and 98981), the large size of the
market (26.1 million worldwide develop DUF annually), and the significant clinical benefits of the proposed
solution will facilitate commercialization of Tele-FootX.

* Information listed above is at the time of submission. *

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