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

Sponsor
Gazi University (Other)
Overall Status
Completed
CT.gov ID
NCT05747872
Collaborator
(none)
72
1
2
7.3
9.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Buerger Allen Exercises
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Mar 10, 2022
Actual Primary Completion Date :
Jul 15, 2022
Actual Study Completion Date :
Oct 17, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Ankle Brachial Index (ABI) [Change from baseline Ankle Brachial İndex (ABI) at 12 weeks]

    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).

  2. Change in ulcer surface area [Change from baseline ulcer surface area at 12 weeks]

    Ulcer size was measured in centimeters. Ulcer surface area was measured using a scaled transparent measurement paper.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gazi University Ankara Çankaya Turkey 06490

Sponsors and Collaborators

  • Gazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Naile Bilgili, Professor, Gazi University
ClinicalTrials.gov Identifier:
NCT05747872
Other Study ID Numbers:
  • 2021 - 814
First Posted:
Feb 28, 2023
Last Update Posted:
Feb 28, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2023