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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
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.
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.
National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University
Beijing, Beiijng, China
RECRUITINGRate of adverse event
The rate of adverse event in 24 hours after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Time frame: 0 hour - 24 hours
Rate of adverse event
The rate of adverse event in 7 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Time frame: 0 Day - 7 Days
Rate of serious adverse event
The rate of serious adverse event in 1 hour after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Time frame: 0 hour - 1 hour
Rate of cure rate
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.
Time frame: 0 day - 34 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.