Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05747872
Other study ID # 2021 - 814
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT02652754 - Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Diabetic Foot Ulcers Phase 1
Completed NCT01070433 - A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers Phase 2
Completed NCT00971048 - Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds N/A
Terminated NCT00762138 - The AutoloGel™ Post-Market Surveillance (TAPS) Program N/A
Completed NCT00578604 - Non-Invasive Assessment of Wound Healing With Optical Methods N/A
Completed NCT05417425 - Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers Phase 1
Completed NCT02631512 - Evaluation of Woulgan in Diabetic Foot Ulcer Phase 4
Completed NCT02222376 - Effect of Topic Pirfenidone in Diabetic Ulcers Phase 3
Terminated NCT01816633 - Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers N/A
Completed NCT01221207 - Instant Total Contact Cast to Heal Diabetic Foot Ulcers N/A
Completed NCT01454401 - LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers N/A
Withdrawn NCT01105884 - Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers N/A
Completed NCT01291160 - Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers Phase 2/Phase 3
Completed NCT00536744 - Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers Phase 3
Terminated NCT00316537 - Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers Phase 1/Phase 2
Completed NCT00013299 - Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3 Phase 2
Completed NCT00013286 - A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk Phase 2
Terminated NCT02667327 - A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer Phase 3
Not yet recruiting NCT00916292 - Safety Study of Topical Human FGF-1 for Wound Healing Phase 1
Completed NCT01154374 - A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot) Phase 2