Micro-mobile Foot Compression and Diabetic Foot
Nyckelord
Abstrakt
Datum
| Senast verifierad: | 01/31/2020 |
| Först skickat: | 04/25/2017 |
| Beräknad anmälan inlämnad: | 04/25/2017 |
| Först publicerad: | 04/30/2017 |
| Senaste uppdatering skickad: | 02/11/2020 |
| Senaste uppdatering publicerad: | 02/26/2020 |
| Datum för första inlämnade resultat: | 01/13/2020 |
| Datum för första inlämnade QC-resultat: | 01/13/2020 |
| Datum för först publicerade resultat: | 02/09/2020 |
| Faktiskt startdatum för studien: | 05/01/2017 |
| Uppskattat primärt slutdatum: | 09/08/2018 |
| Beräknat slutfört datum: | 05/13/2020 |
Tillstånd eller sjukdom
Intervention / behandling
Device: Avex Footbeat
Fas
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| 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. |
Urvalskriterier
| Åldrar berättigade till studier | 18 Years Till 18 Years |
| Kön som är berättigade till studier | All |
| Accepterar friska volontärer | Ja |
| Kriterier | 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. |
Resultat
Primära resultatåtgärder
1. Change in Balance From Baseline to 4 Weeks [baseline and 4 weeks.]
2. Change in Skin Perfusion From Baseline to 4 Weeks [Baseline and 4 weeks]
Sekundära resultatåtgärder
1. Change in Lower Extremity Edema From Baseline to 4 Weeks [Baseline and 4 weeks]
2. Change in Plantar Sensation From Baseline to 4-week [Baseline to 4 weeks]
3. Change in Stride Velocity From Baseline to 4-week [Baseline to 4 weeks]
