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 range18 Years – 75 Years

SexALL

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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.
✓. 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.

Exclusion criteria

What they're measuring

brachial-shoulder index

Timeframe: 1 day, after 1 month, after 3 month, after 6 month

Trial details

NCT IDNCT06724276

SponsorTulip Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-10

View on ClinicalTrials.gov More Obliterans, Arteriosclerosis trials