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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer; Wound
• Intervention / Treatment: Other: exercise protocol; Other: aerobic exercise; Other: standard treatment

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatih Enzin, Lecturer; Phone Number: +090 5434587483; Email: fatihenzin@harran.edu.tr

Study Locations

• Turkey
  • Şanlıurfa, Turkey
    • Harran Unıversıty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
kinesiophobia score	Investigation of patients' fear of movement with TAMPA	initial assessment - 12th week

Collaborators and Investigators

• Sponsor: Harran University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: diabetes mellitus, exercise, ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries
• Other Study ID Numbers: diabetic rehabilitation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No