Back to resultsLocal Injection for the Treatment of Chronic Wounds and Pain Caused by Chronic Wounds
Primary Purpose
Pain, Chronic Wound
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Freshly manufactured 35 kDa hyaluronan fragment
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
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.
Sites / Locations
- Huinuode Biotechnology Co., Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HA35 local injection Group
Arm Description
This clinical study used the 35 kDa low molecular weight HA fragment HA35, which was freshly manufactured by mixing bovine testis-derived hyaluronidase PH20 injection (H31022111) with high-molecular-weight HA injection (H20174089) for 20 minutes at room temperature.
Outcomes
Primary Outcome Measures
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".
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".
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".
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".
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".
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05810649
Brief Title
Local Injection for the Treatment of Chronic Wounds and Pain Caused by Chronic Wounds
Official Title
Local Injection Freshly Manufactured 35kDa Hyaluronan Fragment HA35 for Treatment of Chronic Wounds and Pain Caused by Chronic.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2, 2023 (Actual)
Primary Completion Date
August 20, 2023 (Actual)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nakhia Impex LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HA35 local injection Group
Arm Type
Experimental
Arm Description
This clinical study used the 35 kDa low molecular weight HA fragment HA35, which was freshly manufactured by mixing bovine testis-derived hyaluronidase PH20 injection (H31022111) with high-molecular-weight HA injection (H20174089) for 20 minutes at room temperature.
Intervention Type
Drug
Intervention Name(s)
Freshly manufactured 35 kDa hyaluronan fragment
Other Intervention Name(s)
HA35
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound-associated pain measurement
Description
Each participant rated the pain on a scale of 0-10, where 0 represents "no pain" and 10 represents "the most intense pain".
Time Frame
24 hours
Title
Measurement of darkness or redness of the skin surrounding the wounds
Description
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".
Time Frame
10 days
Title
Measurement of dryness and broken areas of the surface of the skin surrounding the wounds
Description
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".
Time Frame
10 days
Title
Measurement of fresh granulation growth on the wounds
Description
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".
Time Frame
10 days
Title
Measurement of wound size
Description
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".
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Huinuode Biotechnology Co., Ltd.
City
Qingdao
Country
China
12. IPD Sharing Statement
Learn more about this trial
Local Injection for the Treatment of Chronic Wounds and Pain Caused by Chronic Wounds
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