NCT05764226

Brief Summary

In this research, the patients with chronic wounds accompanied by pain were treated by injecting freshly manufactured tissue permeable hyaluronan fragment HA35 into the tissue under the heath skin immediately surrounding the chronic wounds.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
Last Updated

March 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

February 16, 2023

Last Update Submit

March 1, 2023

Conditions

Chronic Wounds

Keywords

Hyaluronidase35kDa hyaluronan fragmentHA35Tissue permeabilityChronic woundWound healing

Outcome Measures

Primary Outcomes (1)

  • The pain score

    Primary outcome in this clinical study is the pain score of all kinds of chronic wound, inclouding diabetic chronic wounds, chronic venous wounds, chronic arterial wounds ,traumatic and chronic pressure wounds. The pain scale is a tool typically employed by clinicians for pain assessment. Participants use a specially designed scale to do self-assessment for pain intensity. Each participant rates the pain on a scale of 0-10 where 0 represents "no pain" while 10 represents "the most intensive pain". In this study, the pain intensity was assessed before and after the treatment.

    24 hours

Secondary Outcomes (1)

  • The self-quantitative assessment scale

    10 days

Study Arms (1)

35 kDa HA fragment HA35 injection

EXPERIMENTAL

100 mg of the freshly made 35 kDa low molecular weight hyaluronan fragment HA35 was injected into the tissue under the heath skin immediately surrounding the chronic wounds

Drug: HA35(L20200708MP07707, Ministry of Health, Mongolia)was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)

Interventions

HA35(L20200708MP07707, Ministry of Health, Mongolia)was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)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.

Also known as: HA35
35 kDa HA fragment HA35 injection

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The chronic wounds of painful diabetic wounds, venous wounds, arterial wounds, traumatic and pressure wounds which had 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far East Hospital

Harbin, Heilongjiang, 150000, China

Location

Related Publications (2)

  • Jia X, Shi M, Wang Q, Hui J, Shofaro JH, Erkhembayar R, Hui M, Gao C, Gantumur MA. Anti-Inflammatory Effects of the 35kDa Hyaluronic Acid Fragment (B-HA/HA35). J Inflamm Res. 2023 Jan 13;16:209-224. doi: 10.2147/JIR.S393495. eCollection 2023.

    PMID: 36686276RESULT

  • APPLICATION OF LOW-MOLECULAR-WEIGHT HYALURONIC ACID(LMW-HA) FRAGMENTS(INJECTION) WO/2017/186088 US20200254005 EP3479830 AU2017255833 CA3049286

    RESULT

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
An off-label use of an open label single arm before and after treatment comparison clinical study
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: An open label single arm before and after treatment comparison clinical study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

March 10, 2023

Study Start

July 6, 2020

Primary Completion

December 29, 2022

Study Completion

February 8, 2023

Last Updated

March 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR
Time Frame
published precinical study and international granted patent
Access Criteria
Anti-Inflammatory Effects of the 35kDa Hyaluronic Acid Fragment (B-HA/ HA35); APPLICATION OF LOW-MOLECULAR-WEIGHT HYALURONIC ACID(LMW-HA) FRAGMENTS(INJECTION) WO/2017/186088 US20200254005 EP3479830 AU2017255833 CA3049286
More information

Locations

CN(1)