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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Behavioral: Buerger Allen Exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06490
      • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Buerger Allen Exercises; 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.
No Intervention: Control Grup; The control group received standard wound care but no exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 from baseline Ankle Brachial İndex (ABI) at 12 weeks
Change in ulcer surface area	Ulcer size was measured in centimeters. Ulcer surface area was measured using a scaled transparent measurement paper.	Change from baseline ulcer surface area at 12 weeks

Collaborators and Investigators

• Sponsor: Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): October 17, 2022

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Estimate): February 28, 2023

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetic Neuropathies; Foot Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 2021 - 814

Drug and device information, study documents

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