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Completed

NCT Number: NCT05747872

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Çankaya, 06490, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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;

  • 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 outcomes

  1. Change in Ankle Brachial Index (ABI)

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2023
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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