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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
Min-Sheng General Hospital
About
Eligibility
Locations
Outcomes
Full info

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

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 30, 2005
Last Updated
July 5, 2005
Sponsor
Min-Sheng General Hospital
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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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