Diabetic peripheral vascular disease and sugar foot ulcer
Conditions
Interventions
DC-1 Low Dose Group:Mesenchymal stem cell exosomes (MSC-Exos), 5×10^10 particles per dose, local administration, weekly or as needed (based on wound healing status)
DC-2 Medium Dose Group:Mesenchymal stem cell exosomes (MSC-Exos), 1×10^11 particles per dose, local administration, weekly or as needed (based on wound healing status)
DC-3 High Dose Group:Mesenchymal stem cell exosomes (MSC-Exos), 2×10^11 particles per dose, local administration, weekly or as needed (based on wound healing status)
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years (inclusive), with a history of type 2 diabetes and currently receiving blood glucose control therapy using diabetic medications including insulin; 2. Subject's glycated hemoglobin (HbA1c) test result is = 0.7 and 30 mmHg in at least one lead; 4. Classified as Grade I-II according to the Wagner Ulcer Classification System; 5. The target ulcer must be a diabetic foot wound ulcer meeting all of the following criteria: (1) Ulcer diameter within the range of 1-5 cm; (2) Ulcer located at or below the ankle joint, and persistent for more than 4 weeks without healing; 6. The subject is able and willing to comply with study procedures and standard treatments such as appropriate dressing changes; 7. A signed and dated informed consent form must be obtained from the subject before performing any study-related procedures.
Exclusion criteria
Exclusion criteria: 1. Ulcers with bone exposure or associated with osteomyelitis; 2. Presence of necrosis, suppuration, or sinus tracts that cannot be debrided; 3. Laboratory values at screening: (1) White blood cell (WBC) count 12.0 × 10^9 cells/L; (2) C-reactive protein (CRP) > 100 mg/L; (3) Liver function tests [total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT)] > 3 times the upper limit of normal (ULN); (4) Albumin 3 times the ULN; 4. During screening, any clinically significant condition in the subject's medical history that, in the opinion of the investigator, may interfere with complete wound healing, including but not limited to: (1) Acute or unstable Charcot foot; (2) Current sepsis; (3) Active malignant disease; (4) Acquired immunodeficiency syndrome (AIDS) or HIV-positive status; (5) Severe cerebrovascular disease (acute phase or with significant clinical manifestations) or severe cardiac insufficiency (NYHA Class III or IV); 5. Subject is currently receiving or planning to receive any of the following medications or treatments that may interfere with complete wound healing during the study period: (1) Immunosuppressants (including systemic and local corticosteroid use on the ulcer); (2) Cytotoxic chemotherapy; (3) Cytostatic therapy; (4) Treatment for autoimmune diseases; (5) Dialysis; 6. Previous application of bioengineered tissue or skin substitutes to the potential target ulcer; 7. Psychiatric disorder (e.g., suicidal ideation), current or chronic alcohol abuse, or drug abuse as determined from the subject's history, which in the opinion of the investigator may pose a threat to subject compliance; 8. Any other factor that, in the investigator's opinion, may affect study participation and/or follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicities (DLTs) occurring within 28 days after dosing;Incidence and types of treatment-related adverse events (AEs) and serious adverse events (SAEs) (e.g., local inflammatory reactions, allergic reactions, laboratory abnormalities);Determination of maximum tolerated dose (MTD) and recommended phase II dose (RP2D); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete closure rate of target ulcers at 12 weeks (defined as complete re-epithelialization confirmed on two consecutive visits with no exudate or dressing requirement);Percentage reduction in target ulcer area at 4 weeks;Time to complete healing (from first dose to complete ulcer healing);Incidence of surgical intervention (amputation of toes or limbs); | — |
Countries
China
Contacts
Public ContactZheng Chao
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed