drugset / Trial / NCT00117364

Effect of SACCHACHITIN on Healing of a Chronic Wound

NCT00117364 ↗

Phase 2 Unknown 30 enrolled Min-Sheng General Hospital
Non-randomizedCrossoverSingle-blindTreatment

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.

Timeline

Start
2005-01
Primary completion
—
Completion
2005-06

Drugs

EvaluationDrugModalityDoseRoute
Subject SACCHACHITIN Unknown — —

Indications

No indication recorded.