Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia

Launched by UPECLIN HC FM BOTUCATU UNESP · Mar 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for patients with critical limb ischemia (CLI), a serious condition caused by poor blood flow to the legs, often leading to ulcers or wounds that don’t heal. The trial will test the safety and effectiveness of a type of cell therapy using stem cells taken from the patient's own abdominal fat. These stem cells will be injected into the area around the ulcers to help promote healing. Participants will be divided into two groups: one will receive this new treatment while the other will get standard wound care with special dressings.

To join the trial, participants must be between 65 and 74 years old, have severely restricted blood flow to their legs, and have ulcers that haven’t improved despite previous treatments. Participants will be monitored over 120 days to see if their wounds heal and to check for any side effects. This trial is important because it may offer a new option for people who have not responded to other treatments and face the risk of amputation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Absence of distal pulses in the leg (anterior tibial and posterior tibial) and presence or absence of popliteal pulse.
• • Peripheral Arterial Disease (PAD).
• • Having foot or leg ulcer(s) (distal third) with a minimum area of 1cm2 and a maximum of 3 ulcers totaling up to 20cm2 in the lower limb.
• • Having previously received conventional dressing treatment for ulcer indicating no improvement over a minimum period of 3 weeks (antibiotic therapy - if necessary - local care such as mechanical, surgical or chemical debridements - if necessary, dressings).
• • PAD with IC classified as Fontaine IV and Rutherford 5.
• • Having Ankle Brachial Index (ABI) \<0.9 in infragenicular arteries (anterior tibial, posterior tibial, and fibular) or ABI\>1.3 in one or more infragenicular arteries when suffering from chronic DMT2 (disease duration \> 5 years) not subjected to revascularization treatment or subjected to partial revascularization treatment or treatment failure (stenosis or occlusion) in the last 12 months.
• • Inability to revascularize the affected limb (do not have visible infragenicular arteries for surgical approach) and or incomplete revascularization of this limb (undergone endovascular and or surgical treatment that was not able to restore infragenicular pulses) and defined by the doctor that the best available treatment from the surgical vascular point of view has already been performed and was not successful in promoting ulcer healing.
• • Drug treatment for PAD and for comorbidities.
• • Availability to attend medical appointments.
• Exclusion criteria:
• • Being pregnant or in the puerperium.
• • Having a healed ulcer during the screening period.
• • Having signs of systemic infection or active infection in the arterial ulcer or infection of surgical prostheses (bypass, pins, screws). They may be eligible again if they have been successfully treated with antibiotics and the infectious focus has been removed.
• • Having an ulcer with devitalized tissue (necrosis). They may be eligible again if they have undergone successful surgical debridement or minor amputations (amputation of toes or limited to the forefoot).
• • Having neoplasia and/or being in chemotherapy or radiotherapy treatment or in remission for less than 6 months.
• • Being on colchicine or immunomodulators.
• • Having infectious diseases such as Human Immunodeficiency Virus (HIV), Hepatitis B and C viruses, Human T-cell Lymphotropic Virus (HTLV); due to the risk of contagion during the manipulation of biological material in the laboratory.
• • Having undergone amputation at the level of the leg or thigh in the limb intended to be studied.
• • Having COVID-19, diagnosed less than 4 weeks ago.