Diabetic Foot Ulcer
Conditions
Keywords
Human placental mesenchymal stem cells, Gel
Brief summary
This study is designated to: 1. investigate the tolerance and safety of treatment of Human placental mesenchymal stem cells gel on Human diabetic foot ulcer. 2. learn the primary effectiveness of Human placental mesenchymal stem cells gel on Human diabetic food ulcer. 3. study the pharmacokinetics of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Interventions
OTHERSingle dose experiments
In single dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient only receive treatment once time.
OTHERMulti-dose experiments
In multi-dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient receive treatment on six consecutive days.
Sponsors
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 and Age ≤ 75 * Type 1 or type 2 diabetes mellitus, glycosylated hemoglobin ≤ 9.0% * Diagnosed as condition of diabetic foot ulcer, Wagner grade at 1 or 2 after clinical treatment * Full understand the informed consent form, and signed it voluntarily
Exclusion criteria
* Pregnant or breast-feed women or plan to pregnant or fail to take an efficient contraception * Be allergic to any component of the drug or showed allergic constitution * Showed a sign of systemic infection, or with complication of ethmyphitis, or osteomyelitis indicated by MRI * Have malignancy in the ulcer pathology test, or have a history of malignant tumor * Unable to clean the wounds due to the formation of tract between the ulcer and other condition * Infected with hepatitis B virus (HBV), hepatitis virus C (HCV), human immunodeficiency virus (HIV), or treponema pallidum * Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 2.5 times of the normal value, or Cr\>200 μmol/L * Have a history of apoplexy, unstable angina pectoris, myocardial infarct * Have a psychiatric history, drug abuse or alcohol abuse history * Had participated in any other clinical trials in the past 3 months * Any other circumstances judged by the researchers disqualify the patient to participate in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse event | 0 hour - 24 hours | The rate of adverse event in 24 hours after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of serious adverse event | 0 hour - 1 hour | The rate of serious adverse event in 1 hour after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer. |
| Rate of cure rate | 0 day - 34 days | Rate of cure rate in 20 days and 34 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer. |
Countries
China
Contacts
Primary ContactSiyang Ni, Doc
Outcome results
None listed