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Status unknownNCT04132635Updated Oct 21, 2019

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

An interventional study of artificial dermis and growth factor in Chronic Wound, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown. Per ClinicalTrials.gov, last updated 2019-10-21.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Sex
All
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Study 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.

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Conditions studied

  • Chronic Wound

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In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's planned enrollment of 64 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    artificial dermis with growth factor

    Device: artificial dermis · Other: growth factor

  • Experimental
    artificial dermis only

    Device: artificial dermis

Interventions

  • Deviceartificial dermis

    artificial dermis will be used after fully debridement of the wound

  • Othergrowth factor

    growth factor

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What researchers measure

Primary outcomes

  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 outcomes

  1. 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%.

    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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04132635
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Oct 21, 2019
Start date
Mar 1, 2020 (estimated)
Primary completion
Feb 28, 2022 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
Oct 21, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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