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NCT06515665 | NOT YET RECRUITING | Diabetic Foot Ulcer


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

Hacettepe University

Information provided by (Responsible Party):

Tezel Yildirim Şahan

Brief Summary:

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.

Condition or disease

Diabetic Foot Ulcer

Intervention/treatment

therapeutic foot orthosis

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 66 participants
Masking : SINGLE
Masking Description : A online site named "randomizer.org " gave us a random queue. Participant do not know their queue.
Primary Purpose : SUPPORTIVE_CARE
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
Actual Study Start Date : 2025-09-30
Estimated Primary Completion Date : 2025-12-30
Estimated Study Completion Date : 2026-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

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

Location Details

NCT06515665


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Locations


Not yet recruiting

Turkey, Kecioren

University of Health Science

Ankara, Kecıoren, Turkey, 06018

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