Effectiveness of Buerger Allen Exercise Among Type 2 Diabetes Mellitus Patients With Foot Ulcer

NCT ID: NCT05747872

Last Updated: 2023-02-28

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2022-10-17

Brief Summary

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This study was conducted to determine the effect of Buerger Allen exercises on lower extremity perfusion and wound healing in patients with foot ulcer type 2 diabetes. The Buerger Allen exercise is a specific exercise that aims to improve circulation in the feet and legs. Buerger Allen exercise is an ideal and noninvasive therapy for diabetic patients with a diabetic foot ulcer as it is an easy-to-learn, repetitive, low-cost, and low-risk physical activity. Subjects were randomly allocated to either the control or intervention group. The ulcers and lower extremity perfusion of the patients in both the intervention and control groups were examined and measured.

Detailed Description

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The purpose of this study was to investigate the effect of Buerger Allen exercises on lower extremity perfusion and wound healing in type 2 diabetic patients with a diabetic foot ulcer. Subjects were recruited by the researcher in the clinics where they received treatment. Randomized controlled study design was used in the study. Patients in the study were allocated to the control and study intervention groups. The data collection form developed by the researcher was used to collect the data. Patients in both groups received standard wound care. Subjects in the study intervention group were asked to exercise twice daily for 12 weeks. The ulcers and lower extremity perfusion of the groups were assessed in the beginning, in the 4th week, and the 12th week. The groups will be compared in terms of the ulcer size and lower extremity perfusion.

Conditions

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Diabetic Foot Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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İntervention Grup

Buerger Allen exercises programme will be applied to the type 2 diabetes mellitus patients with foot ulcer. Patients in the intervention group performed daily Buerger Allen exercises for 12 weeks. Patients in the study intervention group were taught Buerger Allen exercises and were asked to exercise twice daily for 12 weeks. Individuals will be given an exercise diary, including the pictures of the exercises, to better manage this process. Reminder phone calls were made once a week to support the exercise program and increase motivation.

Group Type EXPERIMENTAL

Buerger Allen Exercises

Intervention Type BEHAVIORAL

These exercises are specific exercises aimed at improving circulation in the feet and legs.

While doing the exercises, first of all;

1. The legs are raised at an angle of 45 degrees and supported in this position for 1-3 minutes until the skin turns white.
2. Sit on the edge of the bed and let your legs hang down (make sure there is no pressure behind the knees). In this position, move your foot left and right and up and down for 3 minutes.
3. Lie on your back for 5 minutes keeping your legs warm with a blanket.

Performing all three of these exercises in sequence means 1 session. Exercises are done 2 times a day, at least 3 sessions each time.

Control Grup

The control group received standard wound care but no exercises.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Buerger Allen Exercises

These exercises are specific exercises aimed at improving circulation in the feet and legs.

While doing the exercises, first of all;

1. The legs are raised at an angle of 45 degrees and supported in this position for 1-3 minutes until the skin turns white.
2. Sit on the edge of the bed and let your legs hang down (make sure there is no pressure behind the knees). In this position, move your foot left and right and up and down for 3 minutes.
3. Lie on your back for 5 minutes keeping your legs warm with a blanket.

Performing all three of these exercises in sequence means 1 session. Exercises are done 2 times a day, at least 3 sessions each time.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years or older,
* Patients with type 2 diabetes with foot ulcer
* Receiving oral antidiabetic and/or insulin therapy,
* PEDIS Classification stage 1 and 2
* Does not have communication and mental problems,
* are literate and speak Turkish,
* Patients who volunteered to participate in the study

Exclusion Criteria

* with dementia and mental problems,
* Those with serious diabetes complications such as kidney failure and hemodialysis,
* Patients receiving hyperbaric oxygen therapy, negative pressure wound therapy, epidermal growth factor for wound healing.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Naile Bilgili

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gazi University

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2021 - 814

Identifier Type: -

Identifier Source: org_study_id