Micro-mobile Foot Compression and Diabetic Foot

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03135535
• Collaborator: Avex LLC (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 48.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; PAD; Lower Extremity Edema; Neuropathy;Peripheral; Foot Ulcer, Diabetic; Lymphatic Diseases	Device: Avex Footbeat	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Micro-mobile Foot Compression Device to Improve Motor-function in People With Diabetes and Loss of Protective Sensation
• Actual Study Start Date: May 2, 2017
• Actual Primary Completion Date: Sep 9, 2018
• Actual Study Completion Date: May 14, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Balance From Baseline to 4 Weeks [baseline and 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.

2. Change in Skin Perfusion From Baseline to 4 Weeks [Baseline and 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.

Secondary Outcome Measures

1. Change in Lower Extremity Edema From Baseline to 4 Weeks [Baseline and 4 weeks]

   Edema will be measured by traditional circumference change of ankle. The unit of measurement is cm.

2. Change in Plantar Sensation From Baseline to 4-week [Baseline to 4 weeks]

   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.

3. Change in Stride Velocity From Baseline to 4-week [Baseline to 4 weeks]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Medicine	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine
• Avex LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 10, 2018

More Information

Publications

None provided.

• Responsible Party: Bijan Najafi, PhD, Professor of Surgery, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT03135535
• Other Study ID Numbers: H-37962
• First Posted: May 1, 2017
• Last Update Posted: Oct 28, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Diabetic Foot; Lymphatic Diseases; Foot Ulcer

Study Results

Participant Flow

Arm/Group Title	Avex Footbeat
Arm/Group Description	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. 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.
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Avex Footbeat
Arm/Group Description	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. 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.
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 26.7%
>=65 years	22 73.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.1 (9.7)
Sex: Female, Male (Count of Participants)
Female	19 63.3%
Male	11 36.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 6.7%
Not Hispanic or Latino	20 66.7%
Unknown or Not Reported	8 26.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 3.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	17 56.7%
White	5 16.7%
More than one race	0 0%
Unknown or Not Reported	7 23.3%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Change in Balance From Baseline to 4 Weeks
Description	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.
Time Frame	baseline and 4 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Avex Footbeat
Arm/Group Description	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. 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.
Measure Participants	30
At Baseline	0.94 (0.43)
At 4-week	0.76 (0.32)

2. Primary Outcome

Title	Change in Skin Perfusion From Baseline to 4 Weeks
Description	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.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Avex Footbeat
Arm/Group Description	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. 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.
Measure Participants	30
At Baseline	75.1 (15.8)
At 4-week	75.7 (11.1)

3. Secondary Outcome

Title	Change in Lower Extremity Edema From Baseline to 4 Weeks
Description	Edema will be measured by traditional circumference change of ankle. The unit of measurement is cm.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Avex Footbeat
Arm/Group Description	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. 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.
Measure Participants	30
Baseline	23.1 (2.6)
@4week	23.0 (2.4)

4. Secondary Outcome

Title	Change in Plantar Sensation From Baseline to 4-week
Description	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.
Time Frame	Baseline to 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Avex Footbeat
Arm/Group Description	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. 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.
Measure Participants	30
At Baseline	27.4 (12.6)
At 4-week	23.3 (11.9)

5. Secondary Outcome

Title	Change in Stride Velocity From Baseline to 4-week
Description	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)
Time Frame	Baseline to 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Avex Footbeat
Arm/Group Description	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. 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.
Measure Participants	30
At Baseline	0.87 (0.21)
At 4-week	0.96 (0.23)

Adverse Events

Time Frame	4 weeks
Adverse Event Reporting Description	Serious adverse event (SAE) was defined as any related incident of foot ulcer caused by the proposed footwear/insole Other adverse event (AE) was defined as any related major pain or any other problems associated with provided footwear (e.g. edema, skin redness, callus, etc)
Arm/Group Title	Avex Footbeat
Arm/Group Description	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. 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.
All Cause Mortality
	Avex Footbeat
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	Avex Footbeat
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Avex Footbeat
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.