Combined Treatment for Non-Healing Wounds in Chronic Lower Extremity Arterial Disease: a Comparative Study
NCT ID: NCT06724276
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
116 participants
INTERVENTIONAL
2023-01-09
2025-09-06
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
The study will include 116 participants with long-term non-healing wounds from chronic obliterating disease of the lower extremities across three cities in Kazakhstan.
Groups:
* Main: 58
* Control: 58
* Total: 116
* Main Group: Combined treatment (balloon angioplasty or stenting + fibroblast transplantation).
* Control Group: Endovascular interventions + traditional debridement. Procedures will include balloon angioplasty or stenting, followed by fibroblast transplantation.
TREATMENT
NONE
Study Groups
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combined treatment
Combined treatment (balloon angioplasty or stenting + fibroblast transplantation).
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.
Endovascular treatment
Endovascular interventions + traditional debridement.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients with a history of confirmed stable intermittent lameness, the symptoms of which have been observed continuously for at least 3 months at the time of randomization.
3. Patients with a diagnosis of PAD (code I 70.2 - I 70.9 according to the International Classification of Diseases, 10th revision \[ICD - 10\]), confirmed by the results of ultrasound duplex scanning of blood vessels.
4. Patients whose smoking status remained stable for at least 3 months prior to randomization (for smokers).
5. Patients with an ankle - brachial Doppler index value at rest ≤0.9.
6. Patients with a long-term non-healing wound (more than 1 month) and intermittent claudication with a pain-free walking distance of less than 200 meters.
7. Patients who, in the opinion of the investigator, are able to understand and comply with the study requirements.
8. Before starting any examination procedures by the patient or, if applicable, its legal representative, a signed and dated written informed consent form, as well as any necessary processing permissions personal data.
Exclusion Criteria
2. Pulmonary embolism (PE)
3. Acute infectious diseases
4. Patients who underwent reconstructive intervention on the arteries of the lower extremities (surgical or intravascular) in the last 3 months before randomization.
5. Patients who underwent major cardiac surgery within 6 months prior to randomization.
6. Patients with congestive heart failure III-IV functional class according to classification of the New York Heart Association.
7. Patients with any other disease that significantly limits physical activity, or any other medical condition that, in the opinion of the investigator, may limit the patient's participation in the study.
8. Patients with mental status disorders
9. Patients with a history of hypersensitivity or allergy to a radiopaque substance, similar drugs or excipients.
10. Patients who are pregnant or breastfeeding, or who plan to become pregnant before participating in this study or during the study, or who intend to become an egg donor within the same period of time.
11. Progression of the underlying and concomitant disease
12. High levels of creatinine and urea in a biochemical blood test (creatinine in women: more than 80.0 µmol / l; men: more than 110.0 µmol / l; ); ( Urea in adults under 60 years of age is more than 8.32 mmol/l, adults over 60 years of age are more than 7.5 mmol/l )
13. Presence of peptic ulcer of the stomach and duodenum (DUD)
14. Patients with total thrombosis of the vessels of the lower extremities
18 Years
75 Years
ALL
No
Sponsors
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National Research Oncology and Transplantology Center, Kazakhstan
OTHER
Tulip Medicine
OTHER
Responsible Party
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Azat Chinaliyev
Head of department
Locations
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National Research Oncology Center
Astana, , Kazakhstan
Countries
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Other Identifiers
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NROC
Identifier Type: -
Identifier Source: org_study_id