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Effect of SACCHACHITIN on Healing of a Chronic Wound

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ClinicalTrials.gov Identifier: NCT00117364
Recruitment Status : Unknown
Verified June 2005 by Min-Sheng General Hospital.
Recruitment status was:  Recruiting
First Posted : July 6, 2005
Last Update Posted : July 6, 2005
Sponsor:
Information provided by:
Min-Sheng General Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Wounds Drug: SACCHACHITIN patch Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : January 2005
Estimated Study Completion Date : June 2005

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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

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

ClinicalTrials.gov Identifier: NCT00117364     History of Changes
Other Study ID Numbers: EIRB NO 940318-3
First Posted: July 6, 2005    Key Record Dates
Last Update Posted: July 6, 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