Effect of SACCHACHITIN on Healing of a Chronic Wound

Wounds Clinical Trial

Official title:

Effect of SACCHACHITIN on Healing of Chronic Wound ---A Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00117364
• Other study ID #: EIRB NO 940318-3
• Status: Recruiting
• Phase: Phase 2
• First received: June 30, 2005
• Last updated: July 5, 2005
• Start date: January 2005
• Est. completion date: June 2005

Study information

• Verified date: June 2005
• Source: Min-Sheng General Hospital
• Contact: Sheng-Bin Chen, MD
• Phone: 886-3-3179599
• Email: secretary[@]e-ms.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Skin infection

• Vital signs unstable

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds

Intervention

Drug:
• SACCHACHITIN patch

Locations

Country	Name	City	State
Taiwan	Min-Sheng General Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Min-Sheng General Hospital

Country where clinical trial is conducted

Taiwan,