Micro-mobile Foot Compression and Diabetic Foot

NCT03135535 | Completed Phase 2 Results FDA Device

• 1 other identifier: H-37962
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Lower Extremity Edema From Baseline to 4 Weeks

  Baseline and 4 weeks

• Change in Plantar Sensation From Baseline to 4-week

  Baseline to 4 weeks

• Change in Stride Velocity From Baseline to 4-week

  Baseline to 4 weeks

Study Arms (1)

Avex Footbeat

EXPERIMENTAL

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

Interventions

Avex Footbeat DEVICE

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.

Avex Footbeat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Avex LLC: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related 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 Neuropathy. J Diabetes Sci Technol. 2019 Sep;13(5):847-856. doi: 10.1177/1932296819839703. Epub 2019 Apr 3.

  PMID: 30943782 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Neuritis; Diabetic Foot; Lymphatic Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Prof.
• Organization: Baylor College of Medicine

bijan.najafi@bcm.edu

17137987536

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: May 2, 2017
• Primary Completion: September 9, 2018
• Study Completion: May 14, 2021
• Last Updated: October 28, 2021
• Results First Posted: February 27, 2020

Record last verified: 2021-10

Locations

US (1)