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NCT Number: NCT05422846

Investigation of the Effects of Different Exercise on Wound Healing in Patients wıth Diabetic Foot Wounds

Exercise studies with patients with diabetic foot ulcers are very few. In this disease group, since it is considered dangerous to put a load on the foot, a barrier has been placed between the patients and the exercise. With the study investigators plan to do, investigators will try to exercise in these patients in a controlled manner. Among the patients divided into 3 groups, the 1st group will apply the control group, the 2nd group will perform aerobic exercise, and the 3rd group will apply the exercises investigators have determined as the protocol group. 12 weeks, 2 sessions a week will be exercised with the help of a physiotherapist. Patients will be evaluated at baseline, at the end of week 4, at the end of week 8, and at the end.

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Key information

Conditions

Diabetic Foot Ulcer Behavior Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Ulcer Vascular Diseases Wound Wounds and Injuries

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harran Unıversıty

Sanliurfa, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having been diagnosed with Type II diabetes and having a foot ulcer
  • Being in the 1st or 2nd category according to the Wagner classification
  • Not to have a serious musculoskeletal, cardiac, neurological, etc. systemic disease that may interfere with the research.
  • Not having any communication problems
  • Having the same wound care procedure
  • Not taking any other treatment that may have an effect on the wound.

Exclusion criteria

  • Individuals with a diagnosed psychiatric illness,
  • Individuals who have received any physiotherapy treatment in the last 3 months,
  • Individuals with acute infection,
  • Individuals with toe pressure < 40 mmHg
  • Individuals with Charcot Foot and/or osteomyelitis
  • Individuals with venous ulcer disease
  • Individuals who are morbidly obese (BMI >40) according to body mass index
  • Individuals with incurable proliperative retinopathy

Treatment and study plan

standard treatment

Other

The control group will be provided with the necessary approaches for diabetic foot ulcer care and diaphragmatic breathing exercises.

Other names: control

Aerobic Exercise

Other

The aerobic exercise group will be provided with the necessary approaches for diabetic foot ulcer care and in addition to diaphragmatic breathing exercises, they will be provided with aerobic exercise twice a week with a physiotherapist.

exercise protocol

Other

The protocol exercise group will be provided with the necessary approaches for diabetic foot ulcer care and exercises suitable for the physical condition of the wound and the patient, in addition to diaphragmatic breathing exercises. This group will also work with a physiotherapist twice a week.

Primary outcomes

  1. ulcer area (mm²)

    Time frame: initial assessment- 4th week- 8th week- 12th week

    Calculation of ulcer area with image j program

  2. ulcer depth (mm)

    Time frame: initial assessment - 12th week

    Ulcer depth measurement with sterile wound stick

Secondary outcomes

  1. quality of life score

    Time frame: initial assessment - 12th week

    Investigation of patients' quality of life with Ferrans&Powers quality of life index

  2. sleep quality score

    Time frame: initial assessment - 12th week

    investigating the sleep quality of patients with the Pittsburgh sleep quality index

Other outcomes

  1. kinesiophobia score

    Time frame: initial assessment - 12th week

    Investigation of patients' fear of movement with TAMPA

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study title

Investigation of the Effect of Different Exercise Training on Wound Healing ın Patients With Diabetic Foot Ulcer

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2022
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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