Micro-mobile Foot Compression and Diabetic Foot

Micro-mobile Foot Compression Device to Improve Motor-function in People With Diabetes and Loss of Protective Sensation

Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affected limb.Prevention by identifying people at higher risk is the key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or even venous insufficiency and they subsequently may benefit from graduated compression. However, because of the common association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and the possible resulting gangrene.

A novel micro-mobile foot compression device named Footbeat (AVEX, Inc.) offers alternative means providing lower extremity compression. This device is portable and can be used in a standard diabetic shoes on daily basis, which in turn may improve venous blood and relief from concomitant lower extremity edema. In addition, potential improvement in lower extremity blood flow in response to regular foot compression, could improve balance, gait, skin perfusion, plantar sensation, and overall daily physical activities (e.g. number of taken steps per day, duration of standing, etc).

The purpose of this study is to conduct an observational study with N=30 ambulatory patients with diabetes and loss of protective sensation to assess whether this micro-mobile foot compression device can help improving motor function, lower extremity perfusion, and vascular health.

Study Overview

• Status: Completed
• Conditions: Lymphatic Diseases; Diabetes; Foot Ulcer, Diabetic; PAD; Neuropathy;Peripheral; Lower Extremity Edema
• Intervention / Treatment: Device: Avex Footbeat

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female , age 18 or older with the ability and willingness to provide Informed consent
• Patient is willing to participate in all procedures and follow up evaluations necessary to complete the study
• History of type 2 diabetes confirmed by patient's physician.
• History of peripheral neurpathy .

Exclusion Criteria:

• Patients with severe peripheral vascular disease (ankle-brachial systolic pressure index (ABI) <0.5 or ABI>1.30)
• Patients with active wound infection, or untreated osteomyelitis
• Patients with major foot deformities (e.g. Charcot Foot) or major amputation (e.g. above ankle)
• Unamulatory of those who are unable to independently walk with or without walking assistance, a distance of 40 feet.
• Patients who are unable or unwilling to participate in all procedures and follow up evaluations
• Patients currently on immunosuppressive drugs.
• Pregnant or breast feeding ladies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Avex Footbeat; Subjects will receive a new pair of diabetic shoes with BOA shoelace closure and a pair of AVEX Footbeat insoles, which include a micro-mobile compression pump. The entire system is named 'intervention shoes' for simplicity. They will be instructed to wear the intervention shoes on daily basis for 4 weeks for duration of at least 4 hours per day.

Device: Avex Footbeat; Subjects will receive diabetic shoes equipped with Boa Technology shoelace system and Footbeat compression insoles, which for simplicity will be named intervention shoes. All participants will be asked to wear the intervention shoes for duration of 4-weeks on daily basis (minimum 4 hours per day). Daily use of the intervention shoes will be assumed to improve balance, mobility, plantar sensation, lower extremity edema, and lower extremity skin perfusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Balance From Baseline to 4 Weeks	Balance will be quantified by measuring body sway in medial-lateral direction using a validated wearable sensors technology (Balansens, Biosensics LLC) and body sway change after 4-weeks of daily use of AVEX Footbeat will be assessed compare to baseline. Th unit of measurement is cm.	baseline and 4 weeks.
Change in Skin Perfusion From Baseline to 4 Weeks	Skin perfusion was quantified using Skin Perfusion Pressure Test (SPP) at the lower extremities at baseline and at 4-week (end point). The measurement of SPP was done using a device called Sensilase PAD-IQ (VASAMED). The unit of measurement is mmHg.	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lower Extremity Edema From Baseline to 4 Weeks	Edema will be measured by traditional circumference change of ankle. The unit of measurement is cm.	Baseline and 4 weeks
Change in Plantar Sensation From Baseline to 4-week	The change in plantar sensation after 4-weeks use of AVEX Footbeat will be assessed using vibratory perception threshold (VPT) test. The unit of this measurement is volt.	Baseline to 4 weeks
Change in Stride Velocity From Baseline to 4-week	The change in stride velocity was quantified by gait speed measured using a validated wearable sensor (LEGSys, Biosensics, LLC). The unit of measurement is meter per second (m/s)	Baseline to 4 weeks

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Avex LLC

Publications and helpful links

General Publications

• Kang GE, Zahiri M, Lepow B, Saleem N, Najafi B. The Effect of Daily Use of Plantar Mechanical Stimulation Through Micro-Mobile Foot Compression Device Installed in Shoe Insoles on Vibration Perception, Gait, and Balance in People With Diabetic Peripheral Neuropathy. J Diabetes Sci Technol. 2019 Sep;13(5):847-856. doi: 10.1177/1932296819839703. Epub 2019 Apr 3.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): September 9, 2018
• Study Completion (Actual): May 14, 2021

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Neuromuscular Diseases; Diabetic Foot; Foot Ulcer; Peripheral Nervous System Diseases; Lymphatic Diseases
• Other Study ID Numbers: H-37962

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Only de-identified data and associated results will be published in peer-review papers or scientific abstracts. The de-identified data from changes in primary and secondary outcomes (e.g. changes in balance, gait, physical activity, edema, etc) may be shared upon approval of the sponsor.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes