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| Name | Class |
|---|---|
| Gulhane Training and Research Hospital | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| therapeutic foot orthosis | Active Comparator | 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. |
|
| exercises | Active Comparator | 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. |
|
| control | Active Comparator | this group of participants will be assessed at the beginning and end of the 6 weeks without any intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic foot orthosis | Behavioral | They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Balance Evaluation of Individuals with Diabetic foot | time up and go test | Before and after 6 week |
| Performance Evaluation of Individulas With Diabetic Foot | one minute walk test | before and after 6 week |
| Wound Healing Evaluation of Individulas With Diabetic Foot | Photos will be taken with a phone application called Imit measure. | before and after 6 week |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the effectiveness of the diabetic recovery orthosis and exercises on balance | Comparing week six assessments | before and after 6 week |
| Comparing the effectiveness of the diabetic recovery orthosis and exercises on performance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tezel Y Şahan, phD | Contact | 5056615279 | +90 | fzttezel@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tezel Y Şahan, phD | University of Health science | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Science | Ankara | Kecıoren | 06018 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28614678 | Background | 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. | |
| 30065787 | Background | 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. |
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will be decided after the study is finished.
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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There are 3 groups. Fisrt group has therapeutic foot orthosis. Second group has orthosis and exercises with artificial intelligence. Third group is control group.
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A online site named "randomizer.org " gave us a random queue. Participant do not know their queue.
|
Comparing week six assessments
| before and after 6 week |
| Comparing the effectiveness of the diabetic recovery orthosis and exercises on wound healing | Comparing week six assessments | before and after 6 week |
| 33532602 | Background | 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. |
| 38518039 | Background | 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. |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |