NCT05810649

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Nakhia Impex LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Chronic Wound

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-02
• Primary completion: 2023-08-20
• Completion: 2024-02-25
• First posted: 2023-04-12
• Last updated: 2024-04-17

Locations

1 site across 1 country: China