NCT06724276

Combined Treatment for Non-Healing Wounds in Chronic Lower Extremity Arterial Disease: a Comparative Study

Effectiveness of Combined Treatment Methods for Non-Healing Wounds in Patients with Chronic Lower Extremity Arterial Disease: a Comparative Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Tulip Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Obliterans, Arteriosclerosis
• Peripheral Arterial Disease
• Diabetic Foot

Interventions

Type	Name	Description
PROCEDURE	balloon angioplasty and stenting of lower extremity vessels + fibroblasts	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.
PROCEDURE	balloon angioplasty and stenting of lower extremity vessels	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.

Timeline

• Start date: 2023-01-09
• Primary completion: 2025-07-10
• Completion: 2025-09-06
• First posted: 2024-12-09
• Last updated: 2024-12-12

Locations

1 site across 1 country: Kazakhstan