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

NCT05810649 | Completed

• 1 other identifier: HSHN002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Chronic Wound

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

HA35 local injection Group

EXPERIMENTAL

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.

Drug: Freshly manufactured 35 kDa hyaluronan fragment

Interventions

Freshly manufactured 35 kDa hyaluronan fragment DRUG

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.

Also known as: HA35

HA35 local injection Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nakhia Impex LLC: lead

Study Sites (1)

Huinuode Biotechnology Co., Ltd.

Qingdao, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 12, 2023
• Study Start: April 2, 2023
• Primary Completion: August 20, 2023
• Study Completion: February 25, 2024
• Last Updated: April 17, 2024

Record last verified: 2023-03

Locations

CN (1)