Endovascular interventions, such as balloon angioplasty and stenting, are commonly used for PAD due to their proven safety and effectiveness. However, traditional treatments for chronic non-healing wounds are often insufficient. Advances in cell biotechnology, particularly fibroblast therapy, show promise for enhancing wound healing, as fibroblasts play a crucial role in tissue repair and inflammation. This study aims to develop, assess, and evaluate the safety of a combined treatment approach that incorporates fibroblast therapy with existing methods for managing chronic non-healing wounds in PAD patients.
Chronic obliterative diseases of the lower extremity arteries, or peripheral artery disease (PAD), result from systemic atherosclerosis and affect about 202 million adults globally. This condition, marked by progressive arterial stenosis or occlusion, is associated with significant risk factors such as diabetes, smoking, and hypertension. PAD can lead to symptoms ranging from pain and fatigue to severe complications like non-healing chronic wounds. These wounds impose a substantial economic burden on healthcare systems and significantly impact patients' quality of life. In some countries, over 2.5 million people suffer from chronic non-healing ulcers, with high rates of recurrence and poor healing outcomes. Managing these wounds is costly, with significant indirect costs due to loss of productivity. Post-amputation survival rates are low, and traditional treatments often fail to fully address the issue. Endovascular interventions, such as balloon angioplasty and stenting, are preferred for PAD due to their safety and effectiveness. However, current methods for treating chronic non-healing wounds remain insufficient. Recent advancements in cell biotechnology, particularly fibroblast therapy, show promise for improving wound healing. Fibroblasts play a key role in tissue repair and inflammation. There is a need for more research on the effectiveness of combining fibroblast therapy with existing treatments for chronic non-healing wounds in PAD patients. Addressing this gap could lead to better treatment outcomes and improved quality of life for affected individuals. The aim of this study is to develop, assess the effectiveness, and evaluate the safety of a combined treatment method for managing chronic non-healing wounds in patients with chronic obliterative disease of the lower extremity arteries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
A balloon or a stent of the required size (according to the intrinsic diameter of the affected vessel) is delivered to the affected area, sequential balloon dilatation with exposure of up to 5 minutes or stenting of the vessel is performed. After completion, control angiography is performed with evaluation of the result. Instruments, introdjuncer are removed. Manual compression haemostasis (up to 20 minutes over the puncture site) followed by aseptic pressure dressing on the puncture site for 12 hours with bed rest. After surgery, fibroblasts will be applied to the wound for 24 hours.
A balloon or a stent of the required size (according to the intrinsic diameter of the affected vessel) is delivered to the affected area, sequential balloon dilatation with exposure of up to 5 minutes or stenting of the vessel is performed. After completion, control angiography is performed with evaluation of the result. Instruments, introdjuncer are removed. Manual compression haemostasis (up to 20 minutes over the puncture site) followed by aseptic pressure dressing on the puncture site for 12 hours with bed rest.
National Research Oncology Center
Astana, Kazakhstan
brachial-shoulder index
The Brachial-Shoulder Index (BSI, ratio) is a diagnostic measure used to assess blood flow and detect potential vascular abnormalities. It is calculated by dividing the systolic blood pressure (mmHg) at the shoulder by the systolic blood pressure (mmHg) at the arm (brachial artery). This index helps evaluate the presence of arterial blockages or compression between the shoulder and the arm, which can indicate peripheral vascular disease or other circulatory issues. A reduced BSI may suggest impaired blood flow (mm/sec) and is useful in diagnosing conditions related to upper limb circulation.
Time frame: 1 day, after 1 month, after 3 month, after 6 month
dynamics of wound healing
The dynamics of wound healing refer to the process and progression of tissue repair following an injury. This process involves several key phases:Hemostasis, Inflammation, Proliferation, Maturation. The rate and quality of healing can be influenced by factors such as wound type, underlying health conditions, and treatment methods. Monitoring these dynamics ( in cm\^2) helps assess the effectiveness of interventions and guide clinical decisions
Time frame: 1 day, after 1 month, after 3 month, after 6 month
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