Back to resultsA Trial to Evaluate the Combination Efficacy of Artificial Dermis and Growth Factor in Chronic Wounds Ulcer
Primary Purpose
Chronic Wound
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
artificial dermis
growth factor
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Wound
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
artificial dermis with growth factor
artificial dermis only
Arm Description
Outcomes
Primary Outcome Measures
average closure time
Secondary Outcome Measures
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%.
Full Information
NCT ID
NCT04132635
First Posted
October 17, 2019
Last Updated
October 18, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04132635
Brief Title
A Trial to Evaluate the Combination Efficacy of Artificial Dermis and Growth Factor in Chronic Wounds Ulcer
Official Title
A Randomized, Open-label, Multicenter Clinical Trial to Evaluate the Combination Efficacy of Double-layer Artificial Dermis and Growth Factor in the Treatment of Chronic Wounds Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
artificial dermis with growth factor
Arm Type
Experimental
Arm Title
artificial dermis only
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
artificial dermis
Intervention Description
artificial dermis will be used after fully debridement of the wound
Intervention Type
Other
Intervention Name(s)
growth factor
Intervention Description
growth factor
Primary Outcome Measure Information:
Title
average closure time
Time Frame
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 Outcome Measure Information:
Title
total wound closure rate
Description
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%.
Time Frame
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Trial to Evaluate the Combination Efficacy of Artificial Dermis and Growth Factor in Chronic Wounds Ulcer
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