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

Diabetic Foot Ulcers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05747872
• Other study ID #: 2021 - 814
• Status: Completed
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: October 17, 2022

Study information

• Verified date: February 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 17, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Index (ABI) at 12 weeks
Primary	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