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

Investigation of the Effectiveness of Diabetic Recovery Shoes and Artificial Intelligence Supported Structured Exercise Program in Individuals with Diabetic Foot Receiving Hyperbaric Oxygen Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Behavioral: therapeutic foot orthosis

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
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tezel Y Şahan, phD; Phone Number: +90 5056615279; Email: fzttezel@gmail.com

Study Locations

• Turkey
  • Kecıoren
    • Ankara, Kecıoren, Turkey, 06018
      • University of Health Science
      • Contact: tezel şahan, assoc.prof.; Phone Number: +090 5056615279; Email: fzttezel@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: therapeutic foot orthosis; 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; They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.; Other Names: exercises
Active Comparator: exercises; 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; They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.; Other Names: exercises
Active Comparator: control; 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.; Other Names: exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Collaborators: Gulhane Training and Research Hospital
• Investigators: Study Chair: Tezel Y Şahan, phD, University of Health Science

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: artificial intelligence; diabetic foot ulcer; foot orthoses
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: Effectiveness of Recovery Shoe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: will be decided after the study is finished.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No