Effects of Recombinant Human Granulocyte/Macrophage Colony-Stimulating Factor on Diabetic Lower Extremity Ulcers: Case Series of Nine Patients

Xiaoling Zhang,1,2 Jing Tao,1,2 Song Gong,1,2 Xuefeng Yu,1,2 Shiying Shao1,2 1Division of Endocrinology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, People’s Republic of China; 2Branch of National Clinical Research Center for Metabolic Diseases, Wuhan, Hubei Province, People’s Republic of ChinaCorrespondence: Shiying Shao, Division of Endocrinology, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Jiefang Road 1095, Wuhan, Hubei Province, 430030, People’s Republic of China, Tel +86-13627144576, Fax +86-27-83662883, Email shaoshiyingtj@163.comBackground: Diabetic lower extremity ulcer, including diabetic foot ulcer (DFU) and leg ulcer, is one of the refractory complications of diabetes, the treatment of which is challenging, expensive, and lengthy. Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor (rhGM-CSF) is an immunomodulatory cytokine that has been mainly applied in the treatment of hematological diseases. Clinical evidence regarding GM-CSF in the treatment of diabetic lower extremity ulcers is limited. This study is the first case series that investigates the repurpose effects of rhGM-CSF on diabetic ulcer healing in real clinical practice.Methods: Nine patients diagnosed with diabetes and refractory lower extremity ulcer (ulcer duration ≥ 2 weeks) were included from September 2021 to February 2023 in the Division of Endocrinology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. Patients with Wagner grade ≥ 4 and SINDAD ≥ 5 were excluded. The included subjects were treated with rhGM-CSF plus standard of care (SOC) including glycemic control, foot care education, debridement of necrotic tissues, topical wound dressings, offloading, and infection control when necessary. The observation endpoint was complete epithelialization. Their clinical manifestations, laboratory tests, and therapeutic