Combined Treatment for Non-Healing Wounds in Chronic Lower Extremity Arterial Disease: a Comparat… (NCT06724276) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Combined Treatment for Non-Healing Wounds in Chronic Lower Extremity Arterial Disease: a Comparative Study
Kazakhstan116 participantsStarted 2023-01-09
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
brachial-shoulder index
Timeframe: 1 day, after 1 month, after 3 month, after 6 month
. 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.
. 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.