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NCT Number: NCT05810649

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

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.

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Key information

Conditions

Pain Chronic Wound Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huinuode Biotechnology Co., Ltd.

Qingdao, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: HA35

Primary outcomes

  1. Wound-associated pain measurement

    Time frame: 24 hours

    Each participant rated the pain on a scale of 0-10, where 0 represents "no pain" and 10 represents "the most intense pain".

  2. Measurement of darkness or redness of the skin surrounding the wounds

    Time frame: 10 days

    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".

  3. Measurement of dryness and broken areas of the surface of the skin surrounding the wounds

    Time frame: 10 days

    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".

  4. Measurement of fresh granulation growth on the wounds

    Time frame: 10 days

    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".

  5. Measurement of wound size

    Time frame: 10 days

    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".

Sponsors and collaborators

Lead sponsor

Nakhia Impex LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 12, 2023
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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