Diabetic foot, pressure ulcers or bed sores caused by prolonged bed rest, radiation ulcers, and lower limb vascular disorders
Conditions
Interventions
Intervention group:Exosome gel for application to refractory wounds
Sponsors
Hainan Medical College First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 90 years (inclusive), with no gender restriction. 2.Suffering from chronic non-healing wounds with a disease course of =1 month, including diabetic skin ulcers, pressure ulcers (bedsores), vasculogenic ulcers (arteriovenous ulcers), etc. 3.No response to standard wound treatment. 4.The patient’s primary disease has been effectively controlled. 5.Has been fully informed of the purpose, methods and potential discomfort of the trial, agrees to participate, and voluntarily signs the informed consent form. 6.Has good compliance, is willing to take medication in accordance with the protocol and receive follow-up examinations on time; is able to understand and cooperate in completing various examination procedures.
Exclusion criteria
Exclusion criteria: 1.Wound necrosis, severe lower extremity ischemia without revascularization. 2.Uncontrolled active infection or ongoing infection. 3.History of contact allergy to the study agent, or prior stem cell therapy. 4.Pregnant women, women planning pregnancy in the near future, or lactating women. 5.Male subjects of reproductive potential and female subjects of childbearing potential who are unwilling to sign an agreement to use effective contraception for a total of 12 months during treatment and until the end of follow-up. 6.Subjects with a history of malignant tumor within 5 years prior to screening, or who have received systemic anticancer therapy. 7.Active hepatitis B virus (HBV), hepatitis C virus (HCV) infection, or human immunodeficiency virus (HIV) infection. 8.Patients with a history of organ transplantation or on the organ transplant waiting list. 9.Subjects who have participated in any other clinical trial within 6 months prior to screening. 10.Subjects currently participating in another clinical trial. 11.Poor compliance, making it difficult to complete study procedures. 12.Any other conditions that, in the investigator’s judgment, may increase subject risk or interfere with trial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wound healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local skin irritation reaction;DLQI;Adverse event rate;VAS;Long-term safety follow-up;Laboratory parameters;Granulation tissue coverage percentage;Time to Complete Wound Healing; | — |
Countries
China
Contacts
Public ContactShaowen Cheng
Hainan Medical College First Affiliated Hospital
Outcome results
None listed