Clinical trial NCT06724276: Combined Treatment for Non-Healing Wounds in Chronic Lower Extremity Arterial Disease: a Comparative Study
Official title: Effectiveness of Combined Treatment Methods for Non-Healing Wounds in Patients with Chronic Lower Extremity Arterial Disease: a Comparative Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obliterans, Arteriosclerosis
Peripheral Arterial Disease
Diabetic Foot
Keywords: balloon angioplasty
stenting of vessels
atherosclerosis
diabetes mellitus
fibroblast
Lead sponsor: Tulip Medicine
Sponsor class: OTHER
Collaborators: name: National Research Oncology and Transplantology Center, Kazakhstan
First posted: 2024-12-09
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a randomized controlled trial, adhering to the CONSORT checklist. Randomization will be conducted using the RandStuff online random number generator, where the number on the stationary card will correspond to the patient's number.

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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients aged 18 to 75 years inclusive.
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:

1. Acute myocardial infarction (ACS), acute cerebrovascular accident (stroke)
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

Primary outcomes:
measure: brachial-shoulder index
timeFrame: 1 day, after 1 month, after 3 month, after 6 month
Secondary outcomes:
measure: dynamics of wound healing
timeFrame: 1 day, after 1 month, after 3 month, after 6 month
Other outcomes:
measure: Number of participants
timeFrame: in a month, 3 months, 6 months
measure: Analysis of participants' body weight
timeFrame: in a month, 3 months, 6 months
measure: Assessment of the degree of oxygen saturation of the lower extremities
timeFrame: in a month, 3 months, 6 months
measure: Results of the SF-12 questionnaire
timeFrame: before the tretment, 3 months, 6 months
measure: Activity of Daily Living Index - Bartell Index.
timeFrame: before the tretment, 3 months after the treatment, 6 months after the treatment
Locations:
city: Astana
country: Kazakhstan
facility: National Research Oncology Center
Study officials:
References: