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

Further Study Details: 

Expected Total Enrollment:  30

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.

Ages Eligible for Study:  16 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Skin infection
• Vital signs unstable

Please refer to this study by ClinicalTrials.gov identifier  NCT00117364

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

Taiwan
      Min-Sheng General Hospital, Taoyuan City,  330,  Taiwan; Recruiting

Study chairs or principal investigators

Sheng-Bin Chen, MD,  Principal Investigator,  Min-Sheng General Hospital   

Study ID Numbers:  EIRB NO 940318-3
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 5, 2005
ClinicalTrials.gov Identifier:  NCT00117364
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-07-26