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

NCT ID: NCT04132635

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-06-30

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.

Conditions

Chronic Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

artificial dermis with growth factor

Group Type: EXPERIMENTAL

artificial dermis

Intervention Type: DEVICE

artificial dermis will be used after fully debridement of the wound

growth factor

Intervention Type: OTHER

growth factor

artificial dermis only

Group Type: EXPERIMENTAL

artificial dermis

Intervention Type: DEVICE

artificial dermis will be used after fully debridement of the wound

Interventions

artificial dermis

artificial dermis will be used after fully debridement of the wound

Intervention Type: DEVICE

growth factor

growth factor

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

QK-MP-201903

Identifier Type: -

Identifier Source: org_study_id