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

Nakhia Impex

Status: Completed

Conditions: Chronic Wound; Pain

Treatments: Drug: Freshly manufactured 35 kDa hyaluronan fragment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05810649

HSHN002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

HA35 local injection Group

Experimental group

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.

Treatment:

Drug: Freshly manufactured 35 kDa hyaluronan fragment