Skip to content

A Prospective, Single-Center, Double-Bland, Randomized Controlled Study to Evaluate the Safety and Efficacy of UC-MSCs Injection in Subjects With Diabetic Foot

A Prospective, Single-Center, Double-Bland, Randomized Controlled Study to Evaluate the Safety and Efficacy of UC-MSCs Injection in Subjects With Diabetic Foot

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046179
Enrollment
Unknown
Registered
2021-05-08
Start date
2021-05-10
Completion date
Unknown
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic foot

Interventions

Group A:The umbilical cord mesenchymal stem cells were injected 20 ml
Group B:Routine wound care

Sponsors

Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years; 2. Confirmed diagnosis of diabetic foot; 3. Diabetic foot ulcer lasted more than 2 weeks; 4. Wagner grade I or II, 1 cm2 = 20 mmHg; 5. Fertile women and non sterile men must agree to take effective contraceptive measures within 180 days after the administration of mesenchymal stem cells; 6. Subjects must understand and volunteer to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Overweight, body mass index (BMI) > 30; 2. Patients with uncontrolled diabetes were defined as HbA1c > 12%; 3. Ketoacidosis or hyperosmolar coma patients; 4. To study the patients who underwent recent surgery; 5. Patients with severe dysfunction of heart, liver, lung, kidney and other important organs; 6. Patients with severe coagulation dysfunction; 7. Severe, uncontrollable infection or even sepsis (in accordance with the mild infection standard of diabetic foot of American infectious disease association IDSA and international diabetic foot working group IWGDF, except those that are considered not to affect the study by the researchers); 8. Pregnant and lactating patients; 9. Patients with history of tumor; 10. Severe allergic history; 11. The patient has any potential mental illness of current medical certification; 12. All kinds of acute hepatitis, hepatitis B carriers, syphilis, HIV antibody positive, clear / suspected tuberculosis diagnosis; 13. Patients who ever participated in another clinical trials in recent 3 months; 14. With any other condition which judge by the investigator to unsuitation.

Design outcomes

Primary

MeasureTime frame
Wound healing rate;

Countries

China

Contacts

Public ContactZhu Feng

Changhai Hospital

18801780080@163.com+86 18801780080

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026