Pain Clinical Trial
Official title:
Local Injection Freshly Manufactured 35kDa Hyaluronan Fragment HA35 for Treatment of Chronic Wounds and Pain Caused by Chronic.
NCT number | NCT05810649 |
Other study ID # | HSHN002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2, 2023 |
Est. completion date | February 25, 2024 |
Verified date | March 2023 |
Source | Nakhia Impex LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic wounds are wounds or ulcers that do not heal properly and are generally classified as venous, arterial, diabetic, traumatic and pressure chronic wounds and is often associated with inflammatory and neuropathic pain. Preliminary clinical studies have confirmed that injection of freshly prepared HA35 promoted the healing of chronic wounds and relieved the pain associated with chronic wounds. This clinical study is a prospective repeated experiments. The purpose of this study was to verify the effectiveness of HA35 injection therapy.
Status | Completed |
Enrollment | 24 |
Est. completion date | February 25, 2024 |
Est. primary completion date | August 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - The chronic wounds of painful diabetic wounds, venous wounds, arterial wounds, traumatic and pressure wounds whichvhad not been closed more than 3 months. - All the chronic wounds were clinically presented by surface darkeness and purulent secretions on the wounds, and darkness or redness, swelling, dryness and broken surface of the skin immediately surrounding the wounds. - Subject agrees to be compliant with study related visit and treatment schedule. - Written informed consent. - Adults aged 18-60 years. Exclusion Criteria: - Have a persistent pain resulted from other medical conditions or unknown causes. - History of wound healing abnormalities or a medical condition that is known to be associated with abnormal wound healing. - Subjects with any known coagulation disorder. - Pregnant females. - Be concomitantly participating in another clinical study. |
Country | Name | City | State |
---|---|---|---|
China | Huinuode Biotechnology Co., Ltd. | Qingdao |
Lead Sponsor | Collaborator |
---|---|
Nakhia Impex LLC |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound-associated pain measurement | Each participant rated the pain on a scale of 0-10, where 0 represents "no pain" and 10 represents "the most intense pain". | 24 hours | |
Primary | Measurement of darkness or redness of the skin surrounding the wounds | This participant self-assessment scale was used to compare the darkness or redness of the skin surrounding the wounds before and after treatment. The participant then rated the intensity level using a scale of 0-10, where 0 represents "no" and 10 represents "the most". | 10 days | |
Primary | Measurement of dryness and broken areas of the surface of the skin surrounding the wounds | This participant self-assessment scale was used to compare the dryness and broken areas of the surface of the skin surrounding the wounds before and after the treatment. The participants then rated the intensity level using a scale of 0-10, where 0 represents "no" and 10 represents "the most". | 10 days | |
Primary | Measurement of fresh granulation growth on the wounds | This participant self-assessment scale was used to compare the fresh granulation growth on the surface of the wounds before and after treatment. The participants then rated the intensity level using a scale of 0-10, where 0 represents "no" and 10 represents "the most". | 10 days | |
Primary | Measurement of wound size | This participant self-assessment scale was used to compare the size of the wounds before and after the treatment. The participants then rated the size or area using a scale of 0-10, where 0 represents "no" and 10 represents "the most". | 10 days |
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