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
Verified date | February 2023 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Gazi University | Ankara | Çankaya |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
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 |
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