Micro-mobile Foot Compression and Diabetic Foot
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| ClinicalTrials.gov Identifier: NCT03135535 |
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Recruitment Status :
Completed
First Posted : May 1, 2017
Results First Posted : February 27, 2020
Last Update Posted : October 28, 2021
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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 Type : | Interventional (Clinical Trial) |
| 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 : | September 9, 2018 |
| Actual Study Completion Date : | May 14, 2021 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
- Change in Balance From Baseline to 4 Weeks [ Time Frame: 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.
- Change in Skin Perfusion From Baseline to 4 Weeks [ Time Frame: 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.
- Change in Lower Extremity Edema From Baseline to 4 Weeks [ Time Frame: Baseline and 4 weeks ]Edema will be measured by traditional circumference change of ankle. The unit of measurement is cm.
- Change in Plantar Sensation From Baseline to 4-week [ Time Frame: 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.
- Change in Stride Velocity From Baseline to 4-week [ Time Frame: 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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135535
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
Documents provided by Bijan Najafi, PhD, Baylor College of Medicine:
| 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 Key Record Dates |
| Results First Posted: | February 27, 2020 |
| Last Update Posted: | October 28, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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Peripheral Nervous System Diseases Diabetic Foot Lymphatic Diseases Foot Ulcer Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer Diabetic Angiopathies |
Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases |