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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Wound
• Intervention / Treatment: Device: artificial dermis; Other: growth factor

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: QK-MP-201903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No