Using Macrophage Stimulating Factor to Treat Diabetic Wounds

Study on the Effectiveness and Safety of Topical Human Granulocyte Macrophage Stimulating Factor Gel in the Treatment of Diabetic Wounds During the Granulation Growth Phase

This study is testing a special gel to see if it can help heal stubborn wounds in people with diabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06608303 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of a topical gel containing Human Granulocyte Macrophage Stimulating Factor in promoting healing of diabetic wounds. It involves a randomized controlled design with approximately 40 participants who have confirmed diabetes and are experiencing chronic wounds in the granulation phase. Participants will be randomly assigned to receive either the active treatment or a saline placebo, and their healing progress will be monitored over time. The study aims to provide insights into new treatment options for difficult-to-heal diabetic ulcers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with type 1 or type 2 diabetes and chronic diabetic ulcers in the granulation phase.

Not a fit: Patients with severe uncontrolled diabetes or other serious health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with diabetic wounds, enhancing their quality of life.

How similar studies have performed: While there have been studies exploring similar approaches, the specific use of Macrophage Stimulating Factor for diabetic wounds is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Beijing, Beijing

• Peking University Third Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Long Zhang Executive Deputy Director, Medical Doctor

Conditions Diabetic Wound