Back to resultsInvestigation of the Effects of Different Exercise on Wound Healing in Patients wıth Diabetic Foot Wounds
Primary Purpose
Diabetic Foot Ulcer, Wound
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
standard treatment
aerobic exercise
exercise protocol
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring diabetes mellitus, exercise, ulcer
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
Sites / Locations
- Harran Unıversıty
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
exercise protocol group
aerobic exercise group
control group
Arm Description
The group that applied progressive exercise according to the motivation of patients and healing status of ulcers.
The group performing aerobic exercise with a bicycle ergometer
The group to which standard applications of DFU treatment will be applied
Outcomes
Primary Outcome Measures
ulcer area (mm²)
Calculation of ulcer area with image j program
ulcer depth (mm)
Ulcer depth measurement with sterile wound stick
Secondary Outcome Measures
quality of life score
Investigation of patients' quality of life with Ferrans&Powers quality of life index
sleep quality score
investigating the sleep quality of patients with the Pittsburgh sleep quality index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05422846
Brief Title
Investigation of the Effects of Different Exercise on Wound Healing in Patients wıth Diabetic Foot Wounds
Official Title
Investigation of the Effect of Different Exercise Training on Wound Healing ın Patients With Diabetic Foot Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Wound
Keywords
diabetes mellitus, exercise, ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups to be applied two different exercises progressing together with the control group
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise protocol group
Arm Type
Experimental
Arm Description
The group that applied progressive exercise according to the motivation of patients and healing status of ulcers.
Arm Title
aerobic exercise group
Arm Type
Experimental
Arm Description
The group performing aerobic exercise with a bicycle ergometer
Arm Title
control group
Arm Type
Experimental
Arm Description
The group to which standard applications of DFU treatment will be applied
Intervention Type
Other
Intervention Name(s)
standard treatment
Other Intervention Name(s)
control
Intervention Description
The control group will be provided with the necessary approaches for diabetic foot ulcer care and diaphragmatic breathing exercises.
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
exercise protocol
Intervention Description
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 Outcome Measure Information:
Title
ulcer area (mm²)
Description
Calculation of ulcer area with image j program
Time Frame
initial assessment- 4th week- 8th week- 12th week
Title
ulcer depth (mm)
Description
Ulcer depth measurement with sterile wound stick
Time Frame
initial assessment - 12th week
Secondary Outcome Measure Information:
Title
quality of life score
Description
Investigation of patients' quality of life with Ferrans&Powers quality of life index
Time Frame
initial assessment - 12th week
Title
sleep quality score
Description
investigating the sleep quality of patients with the Pittsburgh sleep quality index
Time Frame
initial assessment - 12th week
Other Pre-specified Outcome Measures:
Title
kinesiophobia score
Description
Investigation of patients' fear of movement with TAMPA
Time Frame
initial assessment - 12th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Harran Unıversıty
City
Şanlıurfa
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Investigation of the Effects of Different Exercise on Wound Healing in Patients wıth Diabetic Foot Wounds
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