Skip to content

Clinical effect and mechanism of GM-CSF in the treatment of diabetic foot ulcer

Clinical effect and mechanism of GM-CSF in the treatment of diabetic foot ulcer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081658
Enrollment
Unknown
Registered
2024-03-07
Start date
2021-12-04
Completion date
Unknown
Last updated
2024-03-11

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

Conditions

Diabetic foot ulcer

Interventions

Test group 1:rhGM-CSF was administered locally to diabetic foot ulcer wounds every three days (2.0µg/c?)
Test group 2:rhGM-CSF was administered locally to diabetic foot ulcer wounds every three days (4.0µg/c?)
Test group 3:rhGM-CSF was administered locally to diabetic foot ulcer wounds every six days (2.0µg/c?)

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) T2DM patients, who met WHO1999 diagnostic criteria; (2) Wagner I-II level is adopted for DFU classification; (3) over 18 years of age; (4) The first-line conventional treatment of diabetic wounds did not heal for 3 weeks.

Exclusion criteria

Exclusion criteria: 1) DKA and hyperosmolar patients; (2) Patients with lower extremity great artery occlusion or ABI< 0.60; (3) PEDIS infection of the foot was classified into grades 3-4; (4) Patients with severe coronary heart disease, cerebral infarction, heart failure, renal failure; (5) Patients with malignant tumors; (6) Patients using immunosuppressants; (7) Pregnant and lactating women.(8) Patients who are participating in other clinical trials; (9) Researchers consider other reasons not appropriate for clinical trial participants.

Design outcomes

Secondary

MeasureTime frame
HE staining;Capillary density analysis;VEGF-A levels;M1/M2 macrophage level;

Primary

MeasureTime frame
Wound area;

Countries

China

Contacts

Public ContactShao Shiying

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

shaoshiyingtj@163.com+86 136 2714 4576

Outcome results

None listed

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