NCT02668042

CompletedPhase 1

The Activity of Tissue Engineering Skin Substitutes

Chinese PLA General Hospital Source

Chinese PLA General Hospital

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CHIH-PLAGH-ST-006

Study Type

interventional

Actual enrollment (reported)

20

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2015

Actual (reported)

Study Completion

December 2015

Actual (reported)

Brief 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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 20 participants
Study completion date: December 2015
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)
Study Completion
December 2015
Actual (reported)
First Submitted
January 21, 2016
Actual (reported)
First Posted
January 29, 2016
Actual (reported)

Last Updated: January 29, 2016
Status Verified: January 2016
Last Update Submitted: January 28, 2016

Conditions

Difficult to Heal Wounds

Outcome Measures

Primary Outcomes (1)

Frequency of Adverse Events
Frequency and severity of Adverse Events
6 months

Secondary Outcomes (1)

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

Other Outcomes (1)

Reduced pain
6 months after treatment

Study Arms (1)

liveness tissue skin

EXPERIMENTAL

Biological: liveness tissue skin

Interventions

liveness tissue skinBiological

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

liveness tissue skin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age17 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Meet difficult had 1 month or more to heal the wound patients
Who signed the informed consent of men or women older than 17 (pregnancy)

Sponsors & Collaborators

Chinese PLA General Hospital
Otherlead

Study Officials

xiaobing Fu
Chinese PLA General Hospital
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Academican

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 29, 2016

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

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

The process of mental stability, can finish the test

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

December 2015

Actual (reported)

Study Completion

December 2015

Actual (reported)

Last Updated

January 29, 2016

Record last verified: 2016-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02668042
Data provider: ClinicalTrials.gov
Source updated: 2016-01-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:27 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (1)

liveness tissue skin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record