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NCT Number: NCT06515665

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

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Science

Ankara, Kecıoren, 06018, Turkey (Türkiye)

Location contact

tezel şahan, assoc.prof.

CONTACT

[email protected]

5056615279 ext. +090

About this study

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. It is also expected to provide evidence to health professionals working in this field.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

therapeutic foot orthosis

Behavioral

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

Other names: exercises

Primary outcomes

  1. Balance Evaluation of Individuals with Diabetic foot

    Time frame: Before and after 6 week

    time up and go test

  2. Performance Evaluation of Individulas With Diabetic Foot

    Time frame: before and after 6 week

    one minute walk test

  3. Wound Healing Evaluation of Individulas With Diabetic Foot

    Time frame: before and after 6 week

    Photos will be taken with a phone application called Imit measure.

Secondary outcomes

  1. Comparing the effectiveness of the diabetic recovery orthosis and exercises on balance

    Time frame: before and after 6 week

    Comparing week six assessments

  2. Comparing the effectiveness of the diabetic recovery orthosis and exercises on performance

    Time frame: before and after 6 week

    Comparing week six assessments

  3. Comparing the effectiveness of the diabetic recovery orthosis and exercises on wound healing

    Time frame: before and after 6 week

    Comparing week six assessments

Study contacts

Contact information is provided by the study sponsor or research team.

Tezel Y Şahan, phD

CONTACT

[email protected]

5056615279 ext. +90

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Gulhane Training and Research Hospital

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 23, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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