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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05422846
• Other study ID #: diabetic rehabilitation
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2023
• Source: Harran University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer
• Wound
• Wounds and Injuries

Intervention

Other:
• standard treatment
The control group will be provided with the necessary approaches for diabetic foot ulcer care and diaphragmatic breathing exercises.
• aerobic exercise
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
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.

Locations

Country	Name	City	State
Turkey	Harran University	Sanliurfa

Sponsors (1)

Lead Sponsor	Collaborator
Harran University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	kinesiophobia score	Investigation of patients' fear of movement with TAMPA	initial assessment - 12th week
Primary	ulcer area (mm²)	Calculation of ulcer area with image j program	initial assessment- 4th week- 8th week- 12th week
Primary	ulcer depth (mm)	Ulcer depth measurement with sterile wound stick	initial assessment - 12th week
Secondary	quality of life score	Investigation of patients' quality of life with Ferrans&Powers quality of life index	initial assessment - 12th week
Secondary	sleep quality score	investigating the sleep quality of patients with the Pittsburgh sleep quality index	initial assessment - 12th week