Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117364
Status:
UNKNOWN
Last Update Posted:
2005-07-06
First Post:
2005-06-30
Brief Title:
Effect of SACCHACHITIN on Healing of a Chronic Wound
Sponsor:
Min-Sheng General Hospital
Organization:
Min-Sheng General Hospital
Study Overview
Official Title:
Effect of SACCHACHITIN on Healing of Chronic Wound ---A Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None