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

Not Applicable

Completed

• Conditions: Pain; Chronic Wound
• Interventions: Drug: Freshly manufactured 35 kDa hyaluronan fragment

• Registration Number: NCT05810649
• Lead Sponsor: Nakhia Impex LLC

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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Study Start: 2023-04-02
• Study First Posted: 2023-04-12
• Primary Completion: 2023-08-20
• Study Completion: 2024-02-25
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HA35 local injection Group	Freshly manufactured 35 kDa hyaluronan fragment	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.

Primary Outcome Measures

Name	Time	Method
Wound-associated pain measurement	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".
Measurement of darkness or redness of the skin surrounding the wounds	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".
Measurement of dryness and broken areas of the surface of the skin surrounding the wounds	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".
Measurement of fresh granulation growth on the wounds	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".
Measurement of wound size	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".

Trial Locations

Locations (1)

Huinuode Biotechnology Co., Ltd.; 🇨🇳 Qingdao, China