Difficult to Healing of Skin Ulcers
Conditions
Brief summary
This study for a six-month trials, Randomized, open, and parallel comparison before and after its own, Stage test includes screening stage, treatment period and follow-up period. In accordance with chronic wound criteria for the patient, By producing the principle of random number, Were randomly divided into UC-MSCs Gel group or Gel group, The researchers according to the situation of wound healing time and decided to use the secondary treatment, To observe the clinical efficacy and safety.
Interventions
BIOLOGICALUC-MSCs Gel group
This study for a six-month trials,Randomized, open, and parallel comparison before and after its own,Stage test includes screening stage, stochastic screening of more than a month difficult to heal wounds 20 people.By generating a random number of principle,Observation of UC-MSCs Gel group patients efficacy, safety and tolerability of selective parameter.
OTHERGel group
This study for a six-month trials,Randomized, open, and parallel comparison before and after its own,Stage test includes screening stage, stochastic screening of more than a month difficult to heal wounds 20 people.By generating a random number of principle,observed and compared Gel group patients may be no efficacy.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 78 Years
Healthy volunteers
Yes
Inclusion criteria
* Older than 17 year old male or female (pregnancy); * Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years of age must be signed by the guardian informed consent; * The process of psychological stability, can finish the tes
Exclusion criteria
* Allergic constitution, or known allergic to pork or beef source products, gao min physique person; * The wound is more than 10 cm by 10 cm; * People with mental illness, drug abusers and or other items; * 1 month used or are using the sugar metabolism of drugs, such as corticosteroids, thiazide diuretics, tricyclic antidepressants, etc; * 3 month participated in other similar test; * Serious infectious disease not controller; * With surgery, such as severe trauma stress situation; * Always had a history of tumor; * Clinical researchers or for other reasons can't cooperate with the doctors, and other information is not suitable for clinical study of patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events | 6 months | Frequency and severity of Adverse Events |
Secondary
| Measure | Time frame |
|---|---|
| Relative Wound Area Regression of 40% or More at 6 Week | 6 week |
Countries
China
Outcome results
None listed