Effect of SACCHACHITIN on Healing of a Chronic Wound
Primary Purpose
Wounds
Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
SACCHACHITIN patch
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring chronic ulcer, poor healing, The patients with a poorly healed wound, in which skin graft is clinically indicated, are included in this study
Eligibility Criteria
Inclusion Criteria: Patients with a poorly healed wound, in which skin graft is clinically indicated Exclusion Criteria: Skin infection Vital signs unstable
Sites / Locations
- Min-Sheng General HospitalRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00117364
Brief Title
Effect of SACCHACHITIN on Healing of a Chronic Wound
Official Title
Effect of SACCHACHITIN on Healing of Chronic Wound ---A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Min-Sheng General Hospital
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
chronic ulcer, poor healing, The patients with a poorly healed wound, in which skin graft is clinically indicated, are included in this study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SACCHACHITIN patch
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a poorly healed wound, in which skin graft is clinically indicated
Exclusion Criteria:
Skin infection
Vital signs unstable
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Bin Chen, MD
Phone
886-3-3179599
Ext
2042
Email
secretary@e-ms.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Cheng Yao, MD
Phone
886-3-3179599
Ext
2039
Email
m000924@e-ms.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Bin Chen, MD
Organizational Affiliation
Min-Sheng General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Min-Sheng General Hospital
City
Taoyuan City
ZIP/Postal Code
330
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Bin Chen, MD
Phone
886-3-3179599
Ext
2042
Email
secreatry@e-ms.com.tw
12. IPD Sharing Statement
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Effect of SACCHACHITIN on Healing of a Chronic Wound
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