Clinical trial NCT06515665: Effectiveness of Diabetic Recovery Shoes and Artificial Intelligence Supported Structured Exercise Program
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: diabetic foot ulcer
foot orthoses
artificial intelligence
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Gulhane Training and Research Hospital
First posted: 2024-07-23
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Balance Evaluation of Individuals with Diabetic foot
timeFrame: Before and after 6 week
measure: Performance Evaluation of Individulas With Diabetic Foot
timeFrame: before and after 6 week
measure: Wound Healing Evaluation of Individulas With Diabetic Foot
timeFrame: before and after 6 week
Secondary outcomes:
measure: Comparing the effectiveness of the diabetic recovery orthosis and exercises on balance
timeFrame: before and after 6 week
measure: Comparing the effectiveness of the diabetic recovery orthosis and exercises on performance
timeFrame: before and after 6 week
measure: Comparing the effectiveness of the diabetic recovery orthosis and exercises on wound healing
timeFrame: before and after 6 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Science
state: Kecıoren
Study officials:
affiliation: University of Health science
name: Tezel Y Şahan, phD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.