Micro-mobile Foot Compression and Diabetic Foot

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135535
• Other study ID #: H-37962
• Status: Completed
• Phase: Phase 2
• Start date: May 2, 2017
• Est. completion date: May 14, 2021

Study information

• Verified date: October 2021
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 14, 2021
• Est. primary completion date: September 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Lower Extremity Edema
• Lymphatic Diseases
• Neuropathy;Peripheral
• PAD
• Peripheral Nervous System Diseases

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Avex LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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
Secondary	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