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Effect of SACCHACHITIN on Healing of a Chronic Wound

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00117364
Enrollment
30
Registered
2005-07-06
Start date
2005-01-31
Completion date
2005-06-30
Last updated
2005-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGSACCHACHITIN patch

Sponsors

Min-Sheng General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Skin infection * Vital signs unstable

Countries

Taiwan

Contacts

Primary ContactSheng-Bin Chen, MD
secretary@e-ms.com.tw886-3-3179599
Backup ContactWei-Cheng Yao, MD
m000924@e-ms.com.tw886-3-3179599

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026