An interventional study of therapeutic foot orthosis in Diabetic Foot Ulcer, sponsored by Hacettepe University. Not yet recruiting at 1 site in Turkey. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Hacettepe University · Not applicable, Interventional, and Supportive care
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.
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: therapeutic foot orthosis
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.
Behavioral: therapeutic foot orthosis
this group of participants will be assessed at the beginning and end of the 6 weeks without any intervention.
Behavioral: therapeutic foot orthosis
They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.
Also known as: exercises
Balance Evaluation of Individuals with Diabetic foot
time up and go test
Time frame: Before and after 6 week
Performance Evaluation of Individulas With Diabetic Foot
one minute walk test
Time frame: before and after 6 week
Wound Healing Evaluation of Individulas With Diabetic Foot
Photos will be taken with a phone application called Imit measure.
Time frame: before and after 6 week
Comparing the effectiveness of the diabetic recovery orthosis and exercises on balance
Comparing week six assessments
Time frame: before and after 6 week
Comparing the effectiveness of the diabetic recovery orthosis and exercises on performance
Comparing week six assessments
Time frame: before and after 6 week
Comparing the effectiveness of the diabetic recovery orthosis and exercises on wound healing
Comparing week six assessments
Time frame: before and after 6 week
Plan to share: No — will be decided after the study is finished.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Hacettepe University