Local Injection for the Treatment of Chronic Wounds and Pain Caused by Chronic Wounds

Pain Clinical Trial

Official title:

Local Injection Freshly Manufactured 35kDa Hyaluronan Fragment HA35 for Treatment of Chronic Wounds and Pain Caused by Chronic.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05810649
• Other study ID #: HSHN002
• Status: Completed
• Phase: N/A
• Start date: April 2, 2023
• Est. completion date: February 25, 2024

Study information

• Verified date: March 2023
• Source: Nakhia Impex LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Our previous study, together with other studies, showed that topical use of the tissue-permeable HA fragment HA35 relieves swelling of the skin and mucosal wounds. In this study, the tissue-permeable 35 kDa HA fragment HA35 was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089). The therapeutic effect of the tissue-permeable HA fragment HA35 for the treatment of pain-associated chronic wounds was studied in a single-arm off-label study before and after treatment comparison.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Chronic Wound
• Pain
• Wounds and Injuries

Intervention

Drug:
• Freshly manufactured 35 kDa hyaluronan fragment
One hundred milligrams of the freshly made 35 kDa low molecular weight HA fragment HA35 was injected into the tissue under the heath skin immediately surrounding the chronic wounds once a day for 10 days.The pain associated with the wounds and degree of wound healing, including the size of the fresh granulation area on the wound; the degree to which the surface of the skin surrounding the wound was dark, red, dry or broken; and the size of the wound, were observed and recorded.

Locations

Country	Name	City	State
China	Huinuode Biotechnology Co., Ltd.	Qingdao

Sponsors (1)

Lead Sponsor	Collaborator
Nakhia Impex LLC

Country where clinical trial is conducted

China, 

Outcome

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