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CompletedNCT02668042MSCsUpdated Jan 29, 2016

The Activity of Tissue Engineering Skin Substitutes

A Phase 1 interventional study of liveness tissue skin in Difficult to Heal Wounds, sponsored by Chinese PLA General Hospital. Completed. Open to participants aged 17 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-29.

Sponsored by Chinese PLA General Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
17 Years to 70 Years
Sex
All
01

Study summary

The main purpose of this experiment was to evaluate the activity of tissue engineering skin substitutes safety and efficacy studies for the treatment of difficult to heal wounds

Read the detailed description

This study for 6 months for a single center, open, randomized, controlled clinical trials before and after itself, test contains preliminary screening, treatment and follow-up after discharge of the patient.After treatment in patients with early debridement, in the case of no infection of living tissue engineering skin substitute transplantation, observe the wound healing after transplantation, chronic wound evaluation activity of tissue engineering skin substitutes in the efficacy and safety of wound healing after transplantation.

02

Conditions studied

  • Difficult to Heal Wounds
03

In context

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Meet difficult had 1 month or more to heal the wound patients
  2. Who signed the informed consent of men or women older than 17 (pregnancy)
  3. Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years old must be signed by the guardian informed consent
  4. The process of mental stability, can finish the test

Exclusion criteria

Exclusion Criteria:

  1. Known allergic to bovine collagen or gao min physique
  2. the wound is greater than the10cm×10cm
  3. People with mental illness, drug abusers and or other items
  4. Pregnant women,Prepare a pregnancy or breast feeding women
  5. 3 months participated in other similar experiment
  6. Serious infectious disease not controller
  7. With surgery, such as severe trauma stress situation
  8. Can not meet the requirement of the long-term follow-up of patients
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    liveness tissue skin

    Biological: liveness tissue skin

Interventions

  • Biologicalliveness tissue skin

    liveness tissue skin safety and effectiveness for the treatment of difficult to heal wounds

06

What researchers measure

Primary outcomes

  1. Frequency of Adverse Events

    Frequency and severity of Adverse Events

    Time frame: 6 months

Secondary outcomes

  1. Relative Wound Area Regression of 40% or More at 6 Week

    Time frame: 6 week

Other outcomes

  1. Reduced pain

    Reduced pain, measured by VAS scale and use of analgesics

    Time frame: 6 months after treatment

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02668042
Lead sponsor
Chinese PLA General Hospital
Responsible party
Xiaobing Fu (Academican, Chinese PLA General Hospital) — Principal investigator
First posted
Jan 29, 2016
Start date
Jan 2012
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jan 29, 2016

Study contacts

xiaobing Fu
principal investigator · Chinese PLA General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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