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

Primary Purpose

Diabetic Foot Ulcers

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Buerger Allen Exercises
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetic Foot Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

İntervention Grup

Control Grup

Arm Description

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.

The control group received standard wound care but no exercises.

Outcomes

Primary Outcome Measures

Change in Ankle Brachial Index (ABI)
To calculate the ABI, each ankle systolic pressure was divided by the brachial systolic pressure and the higher of the two systolic pressures for each leg was divided by the higher of the two arm pressures to get the right and left ABI The score was interpreted as above 0.9 (normal perfusion), 0.71-0.90 (mildly impaired perfusion), 0.41-0.70 (moderately impaired perfusion), below 0.40 (severely impaired perfusion).
Change in ulcer surface area
Ulcer size was measured in centimeters. Ulcer surface area was measured using a scaled transparent measurement paper.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2023
Last Updated
February 17, 2023
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05747872
Brief Title
Effectiveness of Buerger Allen Exercise Among Type 2 Diabetes Mellitus Patients With Foot Ulcer
Official Title
Effectiveness of Buerger Allen Exercise on Lower Extremity Perfusion and Wound Healing Among Type 2 Diabetes Mellitus Patients With Foot Ulcer: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
October 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi 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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
İntervention Grup
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Grup
Arm Type
No Intervention
Arm Description
The control group received standard wound care but no exercises.
Intervention Type
Behavioral
Intervention Name(s)
Buerger Allen Exercises
Intervention Description
These exercises are specific exercises aimed at improving circulation in the feet and legs. While doing the exercises, first of all; The legs are raised at an angle of 45 degrees and supported in this position for 1-3 minutes until the skin turns white. 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. 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.
Primary Outcome Measure Information:
Title
Change in Ankle Brachial Index (ABI)
Description
To calculate the ABI, each ankle systolic pressure was divided by the brachial systolic pressure and the higher of the two systolic pressures for each leg was divided by the higher of the two arm pressures to get the right and left ABI The score was interpreted as above 0.9 (normal perfusion), 0.71-0.90 (mildly impaired perfusion), 0.41-0.70 (moderately impaired perfusion), below 0.40 (severely impaired perfusion).
Time Frame
Change from baseline Ankle Brachial İndex (ABI) at 12 weeks
Title
Change in ulcer surface area
Description
Ulcer size was measured in centimeters. Ulcer surface area was measured using a scaled transparent measurement paper.
Time Frame
Change from baseline ulcer surface area at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Gazi University
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06490
Country
Turkey

12. IPD Sharing Statement

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

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