Obliterans, ArteriosclerosisNCT06724276
Combined Treatment for Non-Healing Wounds in Chronic Lower Extremity Arterial Disease: A Comparative Study
A study testing balloon angioplasty and stenting of lower extremity vessels + fibroblasts and balloon angioplasty and stenting of lower extremity vessels in people with Obliterans, Arteriosclerosis and Peripheral Arterial Disease, run by Tulip Medicine at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obliterans, Arteriosclerosis, Peripheral Arterial Disease, Diabetic Foot
- What is being tested?
- balloon angioplasty and stenting of lower extremity vessels + fibroblasts and balloon angioplasty and stenting of lower extremity vessels
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteKazakhstan
- Study dates
- 9 Jan 2023to 6 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Combined Treatment Methods for Non-Healing Wounds in Patients With Chronic Lower Extremity Arterial Disease: A Comparative Study
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.
Read the 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.
- Being tested
- balloon angioplasty and stenting of lower extremity vessels + fibroblasts, balloon angioplasty and stenting of lower extremity vessels
- Keywords
- balloon angioplasty, stenting of vessels, atherosclerosis, diabetes mellitus, fibroblast
- Medical subject headings
- Arteriosclerosis Obliterans, Peripheral Arterial Disease, Diabetic Foot, Atherosclerosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon angioplasty and stenting of lower extremity vessels + fibroblastsProcedure or surgery
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 vesselsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| combined treatment | Experimental | Combined treatment (balloon angioplasty or stenting + fibroblast transplantation). Receives: Procedure: balloon angioplasty and stenting of lower extremity vessels + fibroblasts |
| Endovascular treatment | Active comparator | Endovascular interventions + traditional debridement. Receives: Procedure: balloon angioplasty and stenting of lower extremity vessels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day, after 1 month, after 3 month, after 6 month
Secondary outcomes (1)
dynamics of wound healing
The dynamics of wound healing refer to the process and progression of tissue repair following an injury. This process involves several key phases:Hemostasis, Inflammation, Proliferation, Maturation. The rate and quality of healing can be influenced by factors such as wound type, underlying health conditions, and treatment methods. Monitoring these dynamics ( in cm^2) helps assess the effectiveness of interventions and guide clinical decisions
Measured: 1 day, after 1 month, after 3 month, after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start9 Jan 2023
- Primary completion10 Jul 2025
- Study completion6 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obliterans, ArteriosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled trial conducted in accordance with CONSORT guidelines. Randomization was performed using the RandStuff online random number generator, with the number on the card corresponding to the patient's sequential number. The study included 116 patients with chronic, non-healing wounds resulting from chronic obliterative lower-extremity diseases. Groups: • Study group: 58 • Control group: 58 • Total: 116 • Study group: received combination treatment (balloon angioplasty or stenting + fibroblast transplantation). • Control group: endovascular interventions + conventional surgical wound debridement. Procedures included balloon angioplasty or stenting followed by allogeneic fibroblast transplantation.
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulip Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Oncology and Transplantology Center, Kazakhstan
- Responsible party
- Principal investigator, Azat Chinaliyev, National Research Oncology and Transplantology Center, Kazakhstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724276
- Sponsor's protocol ID
- NROC
- Status last verified
- Jul 2025
- First submitted
- 11 Jun 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combined Treatment Methods for Non-Healing Wounds in Patients With Chronic Lower Extremity Arterial Disease: A Comparative Study
- ClinicalTrials.gov ID
- NCT06724276
- Acronym / sponsor ID
- NROC
- Keywords
- balloon angioplasty, stenting of vessels, atherosclerosis, diabetes mellitus, fibroblast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Tulip MedicineUniversity, hospital or other
- Collaborators
- National Research Oncology and Transplantology Center, Kazakhstan
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 6 Sep 2025 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized controlled trial conducted in accordance with CONSORT guidelines. Randomization was performed using the RandStuff online random number generator, with the number on the card corresponding to the patient's sequential number. The study included 116 patients with chronic, non-healing wounds resulting from chronic obliterative lower-extremity diseases. Groups: • Study group: 58 • Control group: 58 • Total: 116 • Study group: received combination treatment (balloon angioplasty or stenting + fibroblast transplantation). • Control group: endovascular interventions + conventional surgical wound debridement. Procedures included balloon angioplasty or stenting followed by allogeneic fibroblast transplantation.
| Arm | Type | Receives |
|---|---|---|
| combined treatment | Experimental | Procedure: balloon angioplasty and stenting of lower extremity vessels + fibroblastsCombined treatment (balloon angioplasty or stenting + fibroblast transplantation). |
| Endovascular treatment | Active comparator | Procedure: balloon angioplasty and stenting of lower extremity vesselsEndovascular interventions + traditional debridement. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balloon angioplasty and stenting of lower extremity vessels + fibroblastsA 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 or surgery | combined treatment |
| balloon angioplasty and stenting of lower extremity vesselsA 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. | Procedure or surgery | Endovascular treatment |
Primary outcome
brachial-shoulder index
Time frame: 1 day, after 1 month, after 3 month, after 6 month
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 secondary outcome
dynamics of wound healing
Time frame: 1 day, after 1 month, after 3 month, after 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balloon angioplasty and stenting of lower extremity vessels + fibroblasts and balloon angioplasty and stenting of lower extremity vessels in people with Obliterans, Arteriosclerosis and Peripheral Arterial Disease, run by Tulip Medicine at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brachial-shoulder index (time frame: 1 day, after 1 month, after 3 month, after 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.