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Résztvevőt keres itt: Egyesült Államok2. fázis

Smart Boot Use to Measure Offloading Adherence

A legfontosabb adatok

Ki végzi
University of Southern California
Hol
Downey, Glendale és Los Angeles (Egyesült Államok)Mind a 4 helyszín megnézése
Azonosító
Állapot
Toboroz
Fázis
2. fázis
Résztvevők
210 fő, tervezett
Kezdés
2021. okt. 19.
Tervezett befejezés
2026. márc. 31.
A vizsgálat típusa
Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Offloading Boot
A regiszteradat frissítve
2026. január 16.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 17 feltétel megnézéseKevesebb

Ki vehet részt

  • Male or female
  • ≥18 years old
  • Non-infected, non-ischemic DFU requiring offloading
  • Ambulatory at home with or without assistance
  • Willing and able to provide written informed consent

Ki nem vehet részt

  • Changes in psychotropic or sleep medication in the last 6 weeks
  • Any clinically significant medical or psychiatric condition
  • Ulcer involves bone
  • Ulcer not of diabetic origin
  • HbA1c > 12%
  • Laboratory abnormality that would interfere with the ability to participate in the study
  • Wound present for > 1 year
  • ABI of index limb < 0.6 or non-detectable Doppler, and/or patient being considered for revascularization during the course of the study
  • Acute Charcot neuropathy or a major foot deformity that doesn't allow them to wear the smart boot
  • Amputation proximal to the rearfoot on the affected extremity
  • Concurrently participating in exercise training
  • Unable or unwilling to attend prescribed clinic visits or comply with protocol

Helyszínek itt: Egyesült Államok

  • Rancho Los Amigos National Rehabilitation CenterDowney, Egyesült ÁllamokContact: Fabiola Rodriguez, MDRésztvevőt keres
  • Verdugo Hills Hospital of USCGlendale, Egyesült ÁllamokContact: Fabiola RodriguezRésztvevőt keres
  • Clemente Clinical ResearchLos Angeles, Egyesült ÁllamokContact: Scott MathisRésztvevőt keres
  • Keck Medical Center of USCLos Angeles, Egyesült ÁllamokContact: Fabiola A Rodriguez, MDRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of amputation. Part of the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. Sometimes people don't wear the boot like they are told. The investigators want to compare three different kinds of diabetic boots to see if they can help make it easier for people to wear their boots as instructed.

A teljes eredeti leírásKevesebb

The investigators will look at three groups of participants: the first group will use removable offloading with reinforced education emphasizing continuous wear, including during rest and sleep, and not to remove it at any time. The second group will use removable offloading consistent with standard of care and receive education on recommended wear during walking or standing, with permission to remove the device during rest and sleep. The third group will use a smart removable offloading device that provides real-time adherence feedback via a smartwatch and smartphone, with additional personalized education informed by remotely monitored adherence data.

The investigators will also be looking at how much physical activity, like walking, the participants do. And they will compare how well participants sleep and rate their quality of life in the three different boots. The investigators think that giving participants information about how much they are wearing their boot using readily available technology will help them to follow the doctor's directions better, and help their wounds heal faster.

A vizsgálat 3 csoportja

  • Group 1: Reference GroupMár használt kezelés, összehasonlításként

    The group 1 will receive above-standard of care intervention, which includes wearing a standard removable boot and enhanced eductaion with weekly adherence reinforcement. In this group, participants are interviewed weekly, adherence is reviewed, and education is reinforced at each visit. Participants are instructed to wear the offloading device at all times, including during rest and at night, and not to remove it at any time.

    Kezelés: Offloading Boot

  • Group 2: Control GroupMár használt kezelés, összehasonlításként

    The control group uses removable offloading and represents the standard of care. These participants receive education at baseline and are advised to wear the offloading device during walking or standing; however, they are allowed to remove it during rest and sleep.

    Kezelés: Offloading Boot

  • Group 3: SmartBootA vizsgált kezelés

    The SmartBoot group follows a similar protocol to the control group, but adherence to wearing offloading during weight-bearing activities is reinforced using a smartwatch. The smartwatch provides real-time reminders when participants walk without the offloading device. In addition, data from remote patient monitoring may help personalize education during weekly clinic visits conducted by the research coordinator.

    Kezelés: Offloading Boot

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading
A regiszteradat frissítve
2026. január 16.