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

NAActive, not recruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

January 9, 2023

Primary Completion Date

July 10, 2025

Study Completion Date

September 6, 2025

Conditions
Obliterans, ArteriosclerosisPeripheral Arterial DiseaseDiabetic Foot
Interventions
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.

Trial Locations (1)

010000

National Research Oncology Center, Astana

All Listed Sponsors
collaborator

National Research Oncology and Transplantology Center, Kazakhstan

OTHER

lead

Tulip Medicine

OTHER

NCT06724276 - Combined Treatment for Non-Healing Wounds in Chronic Lower Extremity Arterial Disease: a Comparative Study | Biotech Hunter | Biotech Hunter