A Trial to Evaluate the Combination Efficacy of Artificia... | NCT04132635

Studies
A Trial to Evaluate the Combination Efficacy of Artificial Dermis and Growth Factor in Chronic Wounds Ulcer

NCT04132635

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Oct 21, 2019Actual

Enrollment

64Estimated

Phase

Not Applicable

Conditions

Chronic Wound

Interventions

artificial dermis
growth factor

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Estimated

Primary Completion Date

Feb 28, 2022Estimated

Completion Date

Jun 30, 2022Estimated

First Submitted Date

Oct 17, 2019

First Submission Date that Met QC Criteria

Oct 18, 2019

First Posted Date

Oct 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2019

Last Update Posted Date

Oct 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Double layer artificial dermis repair material has been widely used in scar plastic, burn, trauma, chronic wounds and other aspects of wound repair and reconstruction. In the course of clinical application, we found that for chronic wounds, the combination of artificial dermis and growth factor can shorten the wound healing cycle, and have a positive impact on the economy and psychology of patients. In order to verify this effect, we plan to carry out this study to evaluate whether double-layer artificial dermis repair material combined with growth factor treatment can improve wound closure rate and shorten closure cycle compared with single artificial dermis for chronic wound.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Label	Type	Description	Intervention Names
artificial dermis with growth factor	Experimental		Device: artificial dermis Other: growth factor
artificial dermis only	Experimental		Device: artificial dermis

Name	Type	Description	Arm Group Labels	Other Names
artificial dermis	Device	artificial dermis will be used after fully debridement of the wound	artificial dermis only artificial dermis with growth factor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
average closure time		From the beginning of the treatment period to the time when the survival rate of skin grafting reaches 100% or 12 weeks visit (whichever comes first), record the average time when all the subjects who reach the complete closure of the wound

Secondary Outcomes

Measure	Description	Time Frame
total wound closure rate	The total wound closure rate = (the number of patients who achieved complete wound closure within 12 weeks / the total number of patients in the group) * 100%.	From the beginning of the treatment period to the survival rate of skin grafting reaching 100% or 12 weeks visit (whichever comes first), record the total number of patients who have reached the complete closure of the wound during this period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed as chronic wounds ulcer;
The affected limb has sufficient blood perfusion. The ankle brachial index was 0.65-1.3, or the partial pressure of oxygen was more than 40 mmHg, or Doppler ultrasound showed enough blood flow.
After debridement, the distance between the wound and the edge of other ulcers was >2cm.
After debridement, the area of exposed bone or tendon was >4cm2.
The wound was completely debridement without obvious necrosis, infection control or osteomyelitis control.
The duration of ulcer wound was at least 30 days.
Sign the informed consent voluntarily.

Exclusion Criteria:

Poor control of diabetes (fasting blood glucose ≥ 8.0mmol/l, HbA1c ≥ 12%);
The researchers think that there are factors affecting wound healing, such as the use of corticosteroids, immunosuppressants and other drugs, chemotherapy or radiotherapy within one year.
To receive or plan to receive drugs or treatment, the researchers believe that these drugs or treatment will interfere with or affect the speed and quality of wound healing;
Unstable Charcot's foot or Charcot's joint disease with bone protrusion;
Patients with severe lymphedema, coagulation disorders, autoimmune diseases, cardiovascular and cerebrovascular diseases, and severe hepatopulmonary and renal diseases;
Those who have received hyperbaric oxygen treatment within 5 days before enrollment, or who have received or plan to receive growth factor, tissue-engineered skin or other skin substitutes treatment within 30 days;
Those who have participated in or are participating in other clinical studies within 30 days before screening;
Pregnant, or lactating women;
Poor general condition or other conditions not suitable for the use of double-layer artificial leather repair materials;
Be allergic to collagen or chondroitin sulfate;
Other cases that researchers think are not suitable for the participation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors