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

NCT06724276 | Active Not Recruiting DMC

• 1 other identifier: NROC
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Obliterans, Arteriosclerosis; Peripheral Arterial Disease; Diabetic Foot

Keywords

balloon angioplasty; stenting of vessels; atherosclerosis; diabetes mellitus; fibroblast

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day, after 1 month, after 3 month, after 6 month

Secondary Outcomes (1)

• dynamics of wound healing

  1 day, after 1 month, after 3 month, after 6 month

Other Outcomes (5)

• Number of participants

  in a month, 3 months, 6 months

• Analysis of participants' body weight

  in a month, 3 months, 6 months

• Assessment of the degree of oxygen saturation of the lower extremities

  in a month, 3 months, 6 months

Study Arms (2)

combined treatment

EXPERIMENTAL

Combined treatment (balloon angioplasty or stenting + fibroblast transplantation).

Procedure: balloon angioplasty and stenting of lower extremity vessels + fibroblasts

Endovascular treatment

ACTIVE COMPARATOR

Endovascular interventions + traditional debridement.

Procedure: balloon angioplasty and stenting of lower extremity vessels

Interventions

balloon angioplasty and stenting of lower extremity vessels + fibroblasts PROCEDURE

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.

combined treatment

balloon angioplasty and stenting of lower extremity vessels PROCEDURE

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.

Endovascular treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 18 to 75 years inclusive.
• 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.
• 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.
• Patients whose smoking status remained stable for at least 3 months prior to randomization (for smokers).
• Patients with an ankle - brachial Doppler index value at rest ≤0.9.
• 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.
• Patients who, in the opinion of the investigator, are able to understand and comply with the study requirements.
• 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.

You may not qualify if:

• Acute myocardial infarction (ACS), acute cerebrovascular accident (stroke)
• Pulmonary embolism (PE)
• Acute infectious diseases
• Patients who underwent reconstructive intervention on the arteries of the lower extremities (surgical or intravascular) in the last 3 months before randomization.
• Patients who underwent major cardiac surgery within 6 months prior to randomization.
• Patients with congestive heart failure III-IV functional class according to classification of the New York Heart Association.
• 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.
• Patients with mental status disorders
• Patients with a history of hypersensitivity or allergy to a radiopaque substance, similar drugs or excipients.
• 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.
• Progression of the underlying and concomitant disease
• 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 )
• Presence of peptic ulcer of the stomach and duodenum (DUD)
• Patients with total thrombosis of the vessels of the lower extremities

Sponsors & Collaborators

• Tulip Medicine: lead
• National Research Oncology and Transplantology Center, Kazakhstan: collaborator

Study Sites (1)

National Research Oncology Center

Astana, 010000, Kazakhstan

Location

MeSH Terms

Conditions

Arteriosclerosis Obliterans; Peripheral Arterial Disease; Diabetic Foot; Atherosclerosis; Diabetes Mellitus

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Diabetic Angiopathies; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: December 9, 2024
• Study Start: January 9, 2023
• Primary Completion: July 10, 2025
• Study Completion: September 6, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)