Effectiveness of Diabetic Recovery Shoes and Artificial Intelligence Supported Structured Exercise Program
NCT ID: NCT06515665
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
66 participants
INTERVENTIONAL
2025-09-30
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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therapeutic foot orthosis
foot orthosis will be applied to this group of participants. For 6 weeks they will be asked to use these foot orthoses. Before and after evaluations will be repeated.
therapeutic foot orthosis
They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.
exercises
this group of participants will be exercised with foot orthoses accompanied by artificial intelligence. For 6 weeks, they will be asked to use these foot orthoses and do their exercises. Before and after evaluations will be repeated.
therapeutic foot orthosis
They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.
control
this group of participants will be assessed at the beginning and end of the 6 weeks without any intervention.
therapeutic foot orthosis
They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.
Interventions
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therapeutic foot orthosis
They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* at most one amputated toe, no thumb,
* accessible to electronic devices with internet,
* no vision and hearing problems,
* no problems that may affect cooperation,
* receiving Hyperbaric Oxygen Therapy.
Exclusion Criteria
* having an orthopedic or other neurological problem,
* having a congenital disability,
* having proximal lower extremity,
* amputation excluding the finger,
* having bilateral finger amputation.
40 Years
65 Years
ALL
No
Sponsors
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Hacettepe University
OTHER
Gulhane Training and Research Hospital
OTHER_GOV
Responsible Party
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Tezel Yıldırım Şahan
Associate Professor
Principal Investigators
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Tezel Y Şahan, phD
Role: STUDY_CHAIR
University of Health science
Locations
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University of Health Science
Ankara, Kecıoren, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.
Buldt AK, Menz HB. Incorrectly fitted footwear, foot pain and foot disorders: a systematic search and narrative review of the literature. J Foot Ankle Res. 2018 Jul 28;11:43. doi: 10.1186/s13047-018-0284-z. eCollection 2018.
Collings R, Freeman J, Latour JM, Paton J. Footwear and insole design features for offloading the diabetic at risk foot-A systematic review and meta-analyses. Endocrinol Diabetes Metab. 2020 Apr 11;4(1):e00132. doi: 10.1002/edm2.132. eCollection 2021 Jan.
Ercan E, Aydin G, Erdogan B, Ozcelik F. The effect of hyperbaric oxygen therapy on hematological indices and biochemical parameters in patients with diabetic foot. Medicine (Baltimore). 2024 Mar 22;103(12):e37493. doi: 10.1097/MD.0000000000037493.
Other Identifiers
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Effectiveness of Recovery Shoe
Identifier Type: -
Identifier Source: org_study_id
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