Lower Limb Arterial Ischemic Ulcers
Conditions
Interventions
Control group:Unloaded hydrogel
Test group:Umbilical cord mesenchymal stem cell exocrine combined with water gel
Sponsors
Lecong Hospital of Shunde Foshan
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Participants voluntarily join the study and sign the informed consent form (ICF); 2.?? Age >=18 years at the time of signing ICF, regardless of gender; 3.?? Diagnosis of lower limb arterial ischemic ulcer confirmed by DSA/CTA, clinical history, and presentation, with ulcer duration >=2 weeks?? (If bilateral ulcers present, the investigator selects one limb for study); 4. Ulcer exhibits no exposure of ligaments, tendons, joint capsules, or bones, and no abscess/osteomyelitis; or ??post-debridement ulcer meets above criteria; 5. Ulcer size: 1 cm² <= area <=20 cm²; 6. Ankle-brachial index (ABI) <=0.6 at rest or before revascularization; 7. No planned vascular reconstruction surgery within 2 months; 8. Agreement to use effective contraception during the trial; For females of childbearing potential: negative pregnancy test; 9. Full understanding of trial objectives/requirements and commitment to complete the study.?;
Exclusion criteria
Exclusion criteria: 1. Acute arterial ischemic ulcer or ulcer duration 38°C or 90 bpm; c. Respiratory rate >20 breaths/min or PaCO212×10?/L, or >10% immature leukocytes; 4. Glycated hemoglobin (HbA1c) >12%; 5. Any of:?? - AST/ALT >2.5×upper limit of normal (ULN); - Serum creatinine >=133 µmol/L (1.5 mg/dL); - History of coronary angioplasty, stenting, CABG, MI, unstable angina; - Clinically significant ECG abnormality; - Severe uncontrolled hypertension (SBP >=180 mmHg or DBP >=110 mmHg) or symptomatic hypotension; - Stroke or transient ischemic attack; 6. Skin disorders potentially impairing wound healing; 7. Immunodeficiency, HIV infection, or treatment within 1 month with:?? - Radiotherapy, systemic corticosteroids; - Chemotherapy, growth factors, immunosuppressants; 8. Active malignancy or autoimmune disease; 9. Prior treatment with growth factors, autologous platelet-rich gel, or skin grafting; 10. Known contact allergy to trial agents; 11. Participation in other clinical trials within 10 weeks; 12. Pregnancy or lactation; 13. Active psychiatric disorders; 14. Inability to comprehend the study protocol; 15. Investigator-determined ineligibility due to:?? - Severe comorbidities, or - Factors compromising follow-up/compliance, or - Refusal of supportive therapies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing rate of lower limb arterial ulcer wounds;Percentage reduction in wound surface area; | — |
Secondary
| Measure | Time frame |
|---|---|
| length of hospital stay;quality of life; | — |
Countries
China
Contacts
Public ContactHe Zaopeng
Lecong Hospital of Shunde Foshan
Outcome results
None listed