Effect of SACCHACHITIN on Healing of a Chronic Wound

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by Min-Sheng General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Min-Sheng General Hospital
ClinicalTrials.gov Identifier:
NCT00117364
First received: June 30, 2005
Last updated: July 5, 2005
Last verified: June 2005
  Purpose

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.


Condition Intervention Phase
Wounds
Drug: SACCHACHITIN patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Effect of SACCHACHITIN on Healing of Chronic Wound ---A Clinical Trial

Further study details as provided by Min-Sheng General Hospital:

Estimated Enrollment: 30
Study Start Date: January 2005
Estimated Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a poorly healed wound, in which skin graft is clinically indicated

Exclusion Criteria:

  • Skin infection
  • Vital signs unstable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117364

Contacts
Contact: Sheng-Bin Chen, MD 886-3-3179599 ext 2042 secretary@e-ms.com.tw
Contact: Wei-Cheng Yao, MD 886-3-3179599 ext 2039 m000924@e-ms.com.tw

Locations
Taiwan
Min-Sheng General Hospital Recruiting
Taoyuan City, Taiwan, 330
Contact: Sheng-Bin Chen, MD    886-3-3179599 ext 2042    secreatry@e-ms.com.tw   
Sponsors and Collaborators
Min-Sheng General Hospital
Investigators
Principal Investigator: Sheng-Bin Chen, MD Min-Sheng General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00117364     History of Changes
Other Study ID Numbers: EIRB NO 940318-3
Study First Received: June 30, 2005
Last Updated: July 5, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by Min-Sheng General Hospital:
chronic ulcer
poor healing
The patients with a poorly healed wound, in which skin graft is clinically indicated, are included in this study

ClinicalTrials.gov processed this record on August 28, 2014