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

NCT ID: NCT05422846

Last Updated: 2023-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-07-01

Brief Summary

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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

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Conditions

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Diabetic Foot Ulcer Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups to be applied two different exercises progressing together with the control group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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exercise protocol group

The group that applied progressive exercise according to the motivation of patients and healing status of ulcers.

Group Type EXPERIMENTAL

exercise protocol

Intervention Type OTHER

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.

aerobic exercise group

The group performing aerobic exercise with a bicycle ergometer

Group Type EXPERIMENTAL

aerobic exercise

Intervention Type OTHER

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.

control group

The group to which standard applications of DFU treatment will be applied

Group Type EXPERIMENTAL

standard treatment

Intervention Type OTHER

The control group will be provided with the necessary approaches for diabetic foot ulcer care and diaphragmatic breathing exercises.

Interventions

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standard treatment

The control group will be provided with the necessary approaches for diabetic foot ulcer care and diaphragmatic breathing exercises.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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control

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harran University

OTHER

Sponsor Role lead

Responsible Party

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Fatih Enzin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Harran Unıversıty

Sanliurfa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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diabetic rehabilitation

Identifier Type: -

Identifier Source: org_study_id

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