Not yet recruiting NCT06515665

Effectiveness of Diabetic Recovery Shoes and Artificial Intelligence Supported Structured Exercise Program

No phase Interventional Diabetic Foot Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: therapeutic foot orthosis.
Who it may be relevant to: Registry conditions: Diabetic Foot Ulcer. Basic parameters: 40 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Turkey (Türkiye)
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Investigation of the Effectiveness of Diabetic Recovery Shoes and Artificial Intelligence Supported Structured Exercise Program in Individuals with Diabetic Foot Receiving Hyperbaric Oxygen Therapy

Overview

This study aims to evaluate the effectiveness of the diabetic recovery sandal and artificial intelligence supported structured exercise program in individuals diagnosed with diabetic foot receiving hyperbaric oxygen therapy. The study will include 66 individuals between the ages of 40-65 who have received a diagnosis of diabetic foot from a specialist doctor, have a forefoot wound and receive hyperbaric oxygen therapy. The included individuals will be randomly divided into 3 groups. All participants will be provided with appropriate wound care and dressing and will be randomly divided into 3 groups. Artificial intelligence assisted exercise (exercise group) will be applied to the 1st group. Group 2 will receive artificial intelligence-assisted exercises and healing sandals. For 6 weeks, diabetic foot exercises and diabetic recovery sandal use will be provided (Exercise + sandal group). 3 groups will not receive any contribution (Control group). Balance, performance, wound healing and muscle strength evaluations will be performed before and after the application. Balance assessments will be evaluated by timed get up and walk test, performance by 1 min walk test, wound healing by Imitto measure phone application and muscle strength assessments by manual muscle tests.Awareness of the use of recovery sandals, hyperbaric oxygen therapy and foot exercises will be increased. Attention will be drawn to the creation of new education programs for people with low education or perception, and necessary measures will be taken in cases where risk is identified. In addition, early detection of recurrent ulcers or amputations in individuals who may increase the level of amputation will increase the risk of hospitalization and at the same time increase the cost of care that needs to be spent during hospitalization.

Detailed description

Interventions

Behavioral therapeutic foot orthosis
They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.

Primary outcome measures

Balance Evaluation of Individuals with Diabetic foot [Time frame: Before and after 6 week]
Performance Evaluation of Individulas With Diabetic Foot [Time frame: before and after 6 week]
Wound Healing Evaluation of Individulas With Diabetic Foot [Time frame: before and after 6 week]

Secondary outcome measures (3)

Comparing the effectiveness of the diabetic recovery orthosis and exercises on balance [Time frame: before and after 6 week]
Comparing the effectiveness of the diabetic recovery orthosis and exercises on performance [Time frame: before and after 6 week]
Comparing the effectiveness of the diabetic recovery orthosis and exercises on wound healing [Time frame: before and after 6 week]

Eligibility criteria

Inclusion criteria

individuals were ability to walk 10 meters with a maximum of one support,
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 major amputations,
having an orthopedic or other neurological problem,
having a congenital disability,
having proximal lower extremity,
amputation excluding the finger,
having bilateral finger amputation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Supportive care

Study locations

Turkey (Türkiye) · 1 center

University of Health Science — Ankara

Publications

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. PMID 28614678
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. PMID 30065787
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. PMID 33532602
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. PMID 38518039

Identifiers

NCT: NCT06515665 · Effectiveness of Recovery Shoe

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗