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Effect of SACCHACHITIN on Healing of a Chronic Wound

NCT ID: NCT00117364

Last Updated: 2005-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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Wounds

Keywords

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chronic ulcer poor healing The patients with a poorly healed wound, in which skin graft is clinically indicated, are included in this study

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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SACCHACHITIN patch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Skin infection
* Vital signs unstable
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Min-Sheng General Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Sheng-Bin Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Min-Sheng General Hospital

Locations

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Min-Sheng General Hospital

Taoyuan, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sheng-Bin Chen, MD

Role: CONTACT

Phone: 886-3-3179599

Email: [email protected]

Wei-Cheng Yao, MD

Role: CONTACT

Phone: 886-3-3179599

Email: [email protected]

Facility Contacts

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Sheng-Bin Chen, MD

Role: primary

Other Identifiers

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EIRB NO 940318-3

Identifier Type: -

Identifier Source: org_study_id