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Effect of SACCHACHITIN on Healing of a Chronic Wound
This study is currently recruiting participants.
Verified by Min-Sheng General Hospital, June 2005
Sponsored by: Min-Sheng General Hospital
Information provided by: Min-Sheng General Hospital
ClinicalTrials.gov Identifier: NCT00117364
  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 II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Effect of SACCHACHITIN on Healing of Chronic Wound ---A Clinical Trial

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

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers: EIRB NO 940318-3
Study First Received: June 30, 2005
Last Updated: July 5, 2005
ClinicalTrials.gov Identifier: NCT00117364  
Health Authority: Taiwan: Department of Health

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

Study placed in the following topic categories:
Ulcer

ClinicalTrials.gov processed this record on January 14, 2009