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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Diabetic Foot Ulcer, Wound

Intervention / Treatment
-----------------
* Other: standard treatment
* Other: aerobic exercise
* Other: exercise protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups to be applied two different exercises progressing together with the control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise protocol group<br>The group that applied progressive exercise according to the motivation of patients and healing status of ulcers. | Other: exercise protocol<br>* 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.<br>|
| Experimental: aerobic exercise group<br>The group performing aerobic exercise with a bicycle ergometer | Other: aerobic exercise<br>* 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.<br>|
| Experimental: control group<br>The group to which standard applications of DFU treatment will be applied | Other: standard treatment<br>* The control group will be provided with the necessary approaches for diabetic foot ulcer care and diaphragmatic breathing exercises.<br>* Other names: control;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ulcer area (mm²) | Calculation of ulcer area with image j program | initial assessment- 4th week- 8th week- 12th week | 
| ulcer depth (mm) | Ulcer depth measurement with sterile wound stick | initial assessment - 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life score | Investigation of patients' quality of life with Ferrans&Powers quality of life index | initial assessment - 12th week | 
| sleep quality score | investigating the sleep quality of patients with the Pittsburgh sleep quality index | initial assessment - 12th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus, exercise, ulcer