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Effect of SACCHACHITIN on Healing of a Chronic Wound

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2005 by Min-Sheng General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00117364
First Posted: July 6, 2005
Last Update Posted: December 9, 2005
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. Read our disclaimer for details.
Information provided by:
Min-Sheng General Hospital
  Purpose

SACCHACHITIN gel, prepared from the waste residue of the fruiting body of Ganoderma tsugae, was used in a previous study to enhance skin wound healing in animal models. In the present study, the effects of the gel on the activity of matrix metalloproteinases (MMPs) and vascular endothelial growth factor (VEGF) as well as on the healing of skin wounds in humans are estimated by a clinical trial.

The hypothesis regarding the poor healing of the wound is the over-expression of MMP and the inhibition of the angiogenic factors. From the previous animal study, the effect of SACCHACHITIN was to inhibit the activity of MMP and stimulation of VEGF and we try to prove the effect over the human wounds from this clinical trial.

Patients with a poorly healed wound, in which skin graft is clinically indicated, are included in this study. The exudates from the wound are collected and analyzed for the activity and concentration of VEGF and MMP. The change of the healing process is recorded.

Positive results are expected from the clinical trial and the patients will get another choice for the treatment of the chronic wound other than skin grafting.


Condition Intervention Phase
Wounds Drug: SACCHACHITIN patch Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effect of SACCHACHITIN on Healing of Chronic Wound ---A Clinical Trial

Resource links provided by NLM:


Further study details as provided by Min-Sheng General Hospital:

Estimated Enrollment: 30
Study Start Date: January 2005
Estimated Study Completion Date: June 2005
Detailed Description:

SACCHACHITIN gel, prepared from the waste residue of the fruiting body of Ganoderma tsugae, was used in a previous study to enhance skin wound healing in animal models. In the present study, the effects of the gel on the activity of matrix metalloproteinases (MMPs) and vascular endothelial growth factor (VEGF) as well as on the healing of skin wounds in humans are estimated by a clinical trial.

The hypothesis regarding the poor healing of the wound is the over-expression of MMP and the inhibition of the angiogenic factors. From the previous animal study, the effect of SACCHACHITIN was to inhibit the activity of MMP and stimulation of VEGF and we try to prove the effect over the human wounds from this clinical trial.

Patients with a poorly healed wound, in which skin graft is clinically indicated, are included in this study. The exudates from the wound are collected and analyzed for the activity and concentration of VEGF and MMP. The change of the healing process is recorded.

Positive results are expected from the clinical trial and the patients will get another choice for the treatment of the chronic wound other than skin grafting.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a poorly healed wound, in which skin graft is clinically indicated

Exclusion Criteria:

  • Skin infection
  • Vital signs unstable
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117364


Contacts
Contact: Sheng-Bin Chen, MD 886-3-3179599 ext 2042 secretary@e-ms.com.tw
Contact: Wei-Cheng Yao, MD 886-3-3179599 ext 2039 m000924@e-ms.com.tw

Locations
Taiwan
Min-Sheng General Hospital Recruiting
Taoyuan City, Taiwan, 330
Contact: Sheng-Bin Chen, MD    886-3-3179599 ext 2042    secreatry@e-ms.com.tw   
Sponsors and Collaborators
Min-Sheng General Hospital
Investigators
Principal Investigator: Sheng-Bin Chen, MD Min-Sheng General Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00117364     History of Changes
Other Study ID Numbers: EIRB NO 940318-3
First Submitted: June 30, 2005
First Posted: July 6, 2005
Last Update Posted: December 9, 2005
Last Verified: June 2005

Keywords provided by Min-Sheng General Hospital:
chronic ulcer
poor healing
The patients with a poorly healed wound, in which skin graft is clinically indicated, are included in this study

Additional relevant MeSH terms:
Wounds and Injuries