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

Not Applicable

Completed

• Conditions: Wound; Diabetic Foot Ulcer
• Interventions: Other: aerobic exercise; Other: exercise protocol; Other: standard treatment

• Registration Number: NCT05422846
• Lead Sponsor: Harran University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-21
• Study Start: 2022-08-01
• Primary Completion: 2023-02-01
• Status Verified: 2023-07
• Study Completion: 2023-07-01
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aerobic exercise group	aerobic exercise	The group performing aerobic exercise with a bicycle ergometer
exercise protocol group	exercise protocol	The group that applied progressive exercise according to the motivation of patients and healing status of ulcers.
control group	standard treatment	The group to which standard applications of DFU treatment will be applied

Primary Outcome Measures

Name	Time	Method
ulcer area (mm²)	initial assessment- 4th week- 8th week- 12th week	Calculation of ulcer area with image j program
ulcer depth (mm)	initial assessment - 12th week	Ulcer depth measurement with sterile wound stick

Secondary Outcome Measures

Name	Time	Method
quality of life score	initial assessment - 12th week	Investigation of patients' quality of life with Ferrans\&Powers quality of life index
sleep quality score	initial assessment - 12th week	investigating the sleep quality of patients with the Pittsburgh sleep quality index

Trial Locations

Locations (1)

Harran Unıversıty; 🇹🇷 Şanlıurfa, Turkey