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

NCT06515665 | Not Yet Recruiting

• 1 other identifier: Effectiveness of Recovery Shoe
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

diabetic foot ulcer; foot orthoses; artificial intelligence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Comparing the effectiveness of the diabetic recovery orthosis and exercises on balance

  before and after 6 week

• Comparing the effectiveness of the diabetic recovery orthosis and exercises on performance

  before and after 6 week

• Comparing the effectiveness of the diabetic recovery orthosis and exercises on wound healing

  before and after 6 week

Study Arms (3)

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.

Behavioral: therapeutic foot orthosis

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.

Behavioral: therapeutic foot orthosis

control

ACTIVE COMPARATOR

this group of participants will be assessed at the beginning and end of the 6 weeks without any intervention.

Behavioral: therapeutic foot orthosis

Interventions

therapeutic foot orthosis BEHAVIORAL

They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.

Also known as: exercises

control; exercises; therapeutic foot orthosis

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead
• Gulhane Training and Research Hospital: collaborator

Study Sites (1)

University of Health Science

Ankara, Kecıoren, 06018, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 28614678 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.

  PMID: 30065787 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.

  PMID: 33532602 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.

  PMID: 38518039 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tezel Y Şahan, phD

  University of Health science

  STUDY CHAIR

Central Study Contacts

Tezel Y Şahan, phD

CONTACT

5056615279; fzttezel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A online site named "randomizer.org " gave us a random queue. Participant do not know their queue.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: There are 3 groups. Fisrt group has therapeutic foot orthosis. Second group has orthosis and exercises with artificial intelligence. Third group is control group.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: July 23, 2024
• Study Start: September 30, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)