NCT00117364

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2005

Completed
Last Updated

July 6, 2005

Status Verified

June 1, 2005

First QC Date

June 30, 2005

Last Update Submit

July 5, 2005

Conditions

Wounds

Keywords

chronic ulcerpoor healingThe patients with a poorly healed wound, in which skin graft is clinically indicated, are included in this study

Interventions

SACCHACHITIN patchDRUG

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Skin infection
  • Vital signs unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Min-Sheng General Hospital

Taoyuan, 330, Taiwan

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Sheng-Bin Chen, MD

    Min-Sheng General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Bin Chen, MD

CONTACT

886-3-3179599secretary@e-ms.com.tw

Wei-Cheng Yao, MD

CONTACT

886-3-3179599m000924@e-ms.com.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 6, 2005

Study Start

January 1, 2005

Study Completion

June 1, 2005

Last Updated

July 6, 2005

Record last verified: 2005-06

Locations

TW(1)