Wounds Clinical Trial
Official title:
Effect of SACCHACHITIN on Healing of Chronic Wound ---A Clinical Trial
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment
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