Chronic WoundsNCT05764226
Freshly Manufactured 35kDa Hyaluronan Fragment HA35 for the Treatment of Chronic Wounds
A study testing HA35(L20200708MP07707, Ministry of Health, Mongolia)was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089) in people with Chronic Wounds, run by Nakhia Impex LLC at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Chronic Wounds
- What is being tested?
- HA35(L20200708MP07707, Ministry of Health, Mongolia)was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2020to 8 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study of Freshly Manufactured 35kDa Hyaluronan Fragment HA35 for Treatment of Chronic Wounds
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.
Read the detailed description
Chronic wounds are wounds or ulcers that do not heal properly and are generally classified as venous, arterial, diabetic, traumatic, and pressure chronic wound. Persistent chronic inflammation is a hallmark for chronic wound or trauma and is also often associated with inflammatory and neuropathic pain.
Injections of high molecular weight hyaluronan HA into joint cavity have been used for many years in treatment of joint pain as well as associated inflammation. Still, due to the high viscosity and poor tissue permeability of high molecular weight HA, it is unsuitable for treating chronic wound or trauma pain and the associated inflammation. In this study, the investigators found that hyaluronidase PH20 could cleave high molecular weight hyaluronan into 35kDa low molecular weight hyaluronan fragment HA35. The freshly-made hyaluronan fragment HA35 had great tissue permeability compared with high molecular HA. Our previous clinical studies (http://www.clinicaltrials.gov) have shown freshly-made hyaluronan fragment HA35 effectively treating shoulder, neck and back pain as well as the severe pain associated with shingles. In this study, the tissue-permeable 35kDa hyaluronan fragment HA35 was freshly manufactured by mixing hyaluronidase PH20 injectable solution and high-molecular-weight hyaluronan HA injectable solution. The therapeutic effect of the tissue-permeable hyaluronan fragment HA35 for treatment of pain associated chronic wounds was studied in a single-arm off-label used, before and after treatment comparison, clinical study similar to others.
Both recombinant human hyaluronidase PH20 (Hylenex, Halozyme Inc) and bovine testis-derived hyaluronidase PH20 (H31022111) are able to cleave high molecule weight hyaluronan into 35 kDa hyaluronan fragments HA35 (L20200708MP07707, Ministry of Health, Mongolia). This clinical study uses 35kDa low molecular weight hyaluronan fragment HA35 which was freshly manufactured by mixing bovine testis-derived hyaluronidase PH20 injection (H31022111) with high molecular weight hyaluronan HA injection (H20174089) for 20 minutesat at room temperature.
In this study, 20 hospitalized patients with chronic wounds accompanied by pain were treated with the freshly manufactured 35 kDa low molecular weight hyaluronan fragment HA35. There were 8 patients with diabetic chronic wounds, 4 patients with chronic venous wounds, 2 patients with chronic arterial wounds, 6 patients with traumatic and chronic pressure wounds. Among these patients, there are 12 males and 8 females, having average age of 55±10 years. The creteria for the chronic wound in this study were the wound that has not been healed more than 3 months. All the chronic wounds were associated with significantly pain. All the wounds were clinically presented by surface darkenes and purulent secretions on the wounds, and darkness, redness, swelling and dryness and broken surface of the skin surrounding the wounds. This study is an open-label clinical study in which no information is withheld from participantes and investigators. In this study, the therapeutic effect was studied by comparison of those of before and after treatment in a single-arm study. The pain associated with the wounds and degree of healing of the wounds including the size of fresh granulation area on the wound, the degree of darkness or redness, dryness and broken surface of the skin surrounding the wound, and the size of the wound were observed and recorded.
- Conditions
- Chronic Wounds
- Being tested
- HA35(L20200708MP07707, Ministry of Health, Mongolia)was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)
- Keywords
- Hyaluronidase, 35kDa hyaluronan fragment, HA35, Tissue permeability, Chronic wound, Wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called HA35
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
The self-quantitative assessment scale
The secondary outcome measure is the self-quantitative assessment scale of chronic trauma signs which is a modified version of the Pain Scale. The chronic trauma signs include darkness or redness, dryness and broken skin surface, fresh granulation growth area of the wounds, and the size of the wounds.
The participant rates the intensity level using scale of 0-10 where 0 represents "no dryness and broken surface" while 10 represents "the most intensive dryness and broken surface".
The participant rates the intensity level using scale of 0-10 where 0 represents "no fresh granulation growth" while 10 represents "the most intensive fresh granulation growth" which equals 100% of wound surface area covered by the fresh granulation growth.
The participant rates the size or area using scale of 0-10 where 0 represents "no wound size change at all" while 10 represents wound 100% closed or healed".
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start6 Jul 2020
- Primary completion29 Dec 2022
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open label single arm before and after treatment comparison clinical study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nakhia Impex LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mongolian National University of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764226
- Sponsor's protocol ID
- hui19970909
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 36686276APPLICATION OF LOW-MOLECULAR-WEIGHT HYALURONIC ACID(LMW-HA) FRAGMENTS(INJECTION) WO/2017/186088 US20200254005 EP3479830 AU2017255833 CA3049286
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Freshly Manufactured 35kDa Hyaluronan Fragment HA35 for Treatment of Chronic Wounds
- ClinicalTrials.gov ID
- NCT05764226
- Acronym / sponsor ID
- hui19970909
- Conditions
- Chronic Wounds
- Keywords
- Hyaluronidase, 35kDa hyaluronan fragment, HA35, Tissue permeability, Chronic wound, Wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nakhia Impex LLCIndustry (pharma, biotech, devices)
- Collaborators
- Mongolian National University of Medical Sciences
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic wounds are wounds or ulcers that do not heal properly and are generally classified as venous, arterial, diabetic, traumatic, and pressure chronic wound. Persistent chronic inflammation is a hallmark for chronic wound or trauma and is also often associated with inflammatory and neuropathic pain.
Injections of high molecular weight hyaluronan HA into joint cavity have been used for many years in treatment of joint pain as well as associated inflammation. Still, due to the high viscosity and poor tissue permeability of high molecular weight HA, it is unsuitable for treating chronic wound or trauma pain and the associated inflammation. In this study, the investigators found that hyaluronidase PH20 could cleave high molecular weight hyaluronan into 35kDa low molecular weight hyaluronan fragment HA35. The freshly-made hyaluronan fragment HA35 had great tissue permeability compared with high molecular HA. Our previous clinical studies (http://www.clinicaltrials.gov) have shown freshly-made hyaluronan fragment HA35 effectively treating shoulder, neck and back pain as well as the severe pain associated with shingles. In this study, the tissue-permeable 35kDa hyaluronan fragment HA35 was freshly manufactured by mixing hyaluronidase PH20 injectable solution and high-molecular-weight hyaluronan HA injectable solution. The therapeutic effect of the tissue-permeable hyaluronan fragment HA35 for treatment of pain associated chronic wounds was studied in a single-arm off-label used, before and after treatment comparison, clinical study similar to others.
Both recombinant human hyaluronidase PH20 (Hylenex, Halozyme Inc) and bovine testis-derived hyaluronidase PH20 (H31022111) are able to cleave high molecule weight hyaluronan into 35 kDa hyaluronan fragments HA35 (L20200708MP07707, Ministry of Health, Mongolia). This clinical study uses 35kDa low molecular weight hyaluronan fragment HA35 which was freshly manufactured by mixing bovine testis-derived hyaluronidase PH20 injection (H31022111) with high molecular weight hyaluronan HA injection (H20174089) for 20 minutesat at room temperature.
In this study, 20 hospitalized patients with chronic wounds accompanied by pain were treated with the freshly manufactured 35 kDa low molecular weight hyaluronan fragment HA35. There were 8 patients with diabetic chronic wounds, 4 patients with chronic venous wounds, 2 patients with chronic arterial wounds, 6 patients with traumatic and chronic pressure wounds. Among these patients, there are 12 males and 8 females, having average age of 55±10 years. The creteria for the chronic wound in this study were the wound that has not been healed more than 3 months. All the chronic wounds were associated with significantly pain. All the wounds were clinically presented by surface darkenes and purulent secretions on the wounds, and darkness, redness, swelling and dryness and broken surface of the skin surrounding the wounds. This study is an open-label clinical study in which no information is withheld from participantes and investigators. In this study, the therapeutic effect was studied by comparison of those of before and after treatment in a single-arm study. The pain associated with the wounds and degree of healing of the wounds including the size of fresh granulation area on the wound, the degree of darkness or redness, dryness and broken surface of the skin surrounding the wound, and the size of the wound were observed and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open label single arm before and after treatment comparison clinical study
| Arm | Type | Receives |
|---|---|---|
| 35 kDa HA fragment HA35 injection | Experimental | 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)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 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HA35(L20200708MP07707, Ministry of Health, Mongolia)was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)Also: HA35One 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. | Drug | 35 kDa HA fragment HA35 injection |
Primary outcome
The pain score
Time frame: 24 hours
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.
1 secondary outcome
The self-quantitative assessment scale
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Results publication: PubMed 36686276Jia 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.
- Results publicationAPPLICATION OF LOW-MOLECULAR-WEIGHT HYALURONIC ACID(LMW-HA) FRAGMENTS(INJECTION) WO/2017/186088 US20200254005 EP3479830 AU2017255833 CA3049286
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Chronic Wounds
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HA35(L20200708MP07707, Ministry of Health, Mongolia)was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089) in people with Chronic Wounds, run by Nakhia Impex LLC at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain score (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764226, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.