Macrophage Stimulating Factor in the Treatment of Diabetic Wounds

NCT06608303 | Completed DMC

• 1 other identifier: Long2024-Jinfuning
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

With the aging of the population, the incidence of diseases such as diabetes, chronic atherosclerotic occlusion, cerebrovascular disease, and cancer is increasing year by year, and has led to an increasing incidence of chronic wounds such as diabetic foot, ischaemic ulcers, venous ulcers, pressure injuries, and radiation ulcers. In addition to the high age and chronic diseases that make the treatment of wounds difficult and long, chronic wounds remain in the proliferative stage, unable to carry out normal repair, which is also an important reason for the prolonged healing of wounds, which seriously affects the quality of life of patients and creates a huge social and family burden. In the United States, chronic hard-to-heal wounds exist in approximately 6.5 million people each year, costing the healthcare system more than $25 billion annually and increasing each year with the increased prevalence of diabetes and other diseases that affect wound healing. How to make chronic wounds heal quickly and well is a huge challenge that affects people\'s access to health today. Macrophages are important cells involved in the inflammatory and proliferative phases of wounds, and are thought to play a key role in regulating the inflammatory response of wounds and promoting wound repair and reconstruction. Recombinant human granulocyte macrophage colony-stimulating factor (rhGM-CSF), as a multifunctional haematopoietic factor, can stimulate the proliferation and differentiation of haematopoietic precursor cells to granulocyte macrophage and promote their peripheral transfer, as well as enhance phagocytosis and secretion of granulocytes and macrophages. Therefore rhGM-CSF is thought to have a possible positive role in the treatment of acute and chronic wounds and has been confirmed in several basic and clinical studies. Topical human granulocyte macrophage stimulating factor gel (JinFuNing), which has been approved and marketed by the state for the treatment of acute and chronic wounds, is able to play a role in promoting wound repair, neovascularisation, and epithelial crawling, and has already achieved a certain degree of efficacy in promoting wound healing. This study accumulates clinical evidence-based medical evidence for more precise use of topical human granulocyte macrophage stimulating factor gel, and explores the clinical efficacy and safety of Jinfuning in the granulation growth phase of diabetic wounds.

Conditions

Diabetic Wound

Outcome Measures

Primary Outcomes (1)

• wound area reduction rate

  Pre-treatment area minus post-treatment area, then divided by pre-treatment area

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (3)

• wound healing rate

  From enrollment to the end of treatment at 2 weeks

• Granulation tissue status

  From enrollment to the end of treatment at 2 weeks

• wound infection control

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

Topical Human Granulocyte Macrophage Stimulating Factor Gel

EXPERIMENTAL

The diabetic wounds were treated with Topical Human Granulocyte Macrophage Stimulating Factor Gel for 2 weeks on top of the standard clinical treatment protocol.

Drug: Topical Human Granulocyte Macrophage Stimulating Factor Gel

saline

PLACEBO COMPARATOR

The diabetic wounds were treated with saline for 2 weeks on top of the standard clinical treatment protocol.

Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

Topical Human Granulocyte Macrophage Stimulating Factor Gel DRUG

Human granulocyte macrophage colony-stimulating factor (rhGM-CSF), as a multifunctional haematopoietic factor, stimulates the proliferation and differentiation of haematopoietic precursor cells to granulocyte macrophages and promotes their peripheral translocation, as well as enhances phagocytosis and secretion of granulocytes and macrophages \[11\]. Since macrophages are key players in regulating the inflammatory response of wounds and promoting wound repair, rhGM-CSF is thought to potentially play a positive role in the treatment of acute and chronic wounds.

Topical Human Granulocyte Macrophage Stimulating Factor Gel

Saline (NaCl 0,9 %) (placebo) DRUG

placebo

saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a confirmed diagnosis of type 1 or type 2 diabetes mellitus that meets the standard World Health Organization definition, with blood glucose controlled prior to enrolment and a glycated haemoglobin HbA1c level of less than 10%;
• the type of wound is an ulcer;
• the wound etiology is diabetic, mainly abnormalities in blood glucose, resulting in poor or prolonged healing and requiring standard wound therapy;
• the staging of the wound is in the granulation phase;
• voluntary participation in the study and signing of an informed consent form.

You may not qualify if:

• acute heart attack, heart failure, hepatitis, shock, expiratory failure and other serious diseases that have not been corrected;
• uncontrolled blood glucose, fasting blood glucose \> 15 mmol/L and glycated haemoglobin \> 12%;
• active bleeding in the wound, which does not allow the implementation of the conventional basic treatment plan;
• serum albumin \< 20 g/L; haemoglobin \< 60 g/L; platelets \< 50 x 109/L;
• a state of disseminated infection that is being or will be treated with antibiotics
• patients with advanced malignant tumours;
• active autoimmune disease;
• previous allergy to topical human granulocyte macrophage stimulating factor gel (Jinfuning);
• inability of the patient to co-operate or mental disorder;
• in the judgement of the investigator, the subject has a clearly irremovable cause of wound healing, is unsuitable for the study or is unable to comply with the requirements of the study.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Wound Healing Center

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: October 12, 2024
• Primary Completion: March 12, 2025
• Study Completion: October 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)