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

NCT05747872 | Completed DMC

• 1 other identifier: 2021 - 814
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

İntervention Grup

EXPERIMENTAL

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

Control Grup

NO INTERVENTION

The control group received standard wound care but no exercises.

Interventions

Buerger Allen Exercises 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.

İntervention Grup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 28, 2023
• Study Start: March 10, 2022
• Primary Completion: July 15, 2022
• Study Completion: October 17, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

TU (1)