Diabetic Foot Ulcer
Conditions
Keywords
diabetic foot ulcer, foot orthoses, artificial intelligence
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.
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.
Interventions
BEHAVIORALtherapeutic foot orthosis
They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.
Sponsors
Gulhane Training and Research Hospital
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
A online site named randomizer.org gave us a random queue. Participant do not know their queue.
Intervention model description
There are 3 groups. Fisrt group has therapeutic foot orthosis. Second group has orthosis and exercises with artificial intelligence. Third group is control group.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Balance Evaluation of Individuals with Diabetic foot | Before and after 6 week | time up and go test |
| Performance Evaluation of Individulas With Diabetic Foot | before and after 6 week | one minute walk test |
| Wound Healing Evaluation of Individulas With Diabetic Foot | before and after 6 week | Photos will be taken with a phone application called Imit measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing the effectiveness of the diabetic recovery orthosis and exercises on balance | before and after 6 week | Comparing week six assessments |
| Comparing the effectiveness of the diabetic recovery orthosis and exercises on performance | before and after 6 week | Comparing week six assessments |
| Comparing the effectiveness of the diabetic recovery orthosis and exercises on wound healing | before and after 6 week | Comparing week six assessments |
Countries
Turkey (Türkiye)
Contacts
Primary ContactTezel Y Şahan, phD
Outcome results
None listed