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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04132635
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Chronic Wound Device: artificial dermis Other: growth factor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: artificial dermis with growth factor Device: artificial dermis
artificial dermis will be used after fully debridement of the wound

Other: growth factor
growth factor

Experimental: artificial dermis only Device: artificial dermis
artificial dermis will be used after fully debridement of the wound

Primary Outcome Measures :
  1. 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 Measures :
  1. total wound closure rate [ 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 ]
    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%.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients diagnosed as chronic wounds ulcer;
  2. 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.
  3. After debridement, the distance between the wound and the edge of other ulcers was >2cm.
  4. After debridement, the area of exposed bone or tendon was >4cm2.
  5. The wound was completely debridement without obvious necrosis, infection control or osteomyelitis control.
  6. The duration of ulcer wound was at least 30 days.
  7. Sign the informed consent voluntarily.

Exclusion Criteria:

  1. Poor control of diabetes (fasting blood glucose ≥ 8.0mmol/l, HbA1c ≥ 12%);
  2. 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.
  3. 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;
  4. Unstable Charcot's foot or Charcot's joint disease with bone protrusion;
  5. Patients with severe lymphedema, coagulation disorders, autoimmune diseases, cardiovascular and cerebrovascular diseases, and severe hepatopulmonary and renal diseases;
  6. 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;
  7. Those who have participated in or are participating in other clinical studies within 30 days before screening;
  8. Pregnant, or lactating women;
  9. Poor general condition or other conditions not suitable for the use of double-layer artificial leather repair materials;
  10. Be allergic to collagen or chondroitin sulfate;
  11. Other cases that researchers think are not suitable for the participation.

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University Identifier: NCT04132635    
Other Study ID Numbers: QK-MP-201903
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action