Diabetic WoundPhase 2NCT06492811
Efficacy and Safety of a Hydrogel Containing Cascade Catalytic Enzymes in the Treatment of Diabetic Wounds
A Phase 2 study testing GAT@F nanoenzyme hydrogel complex in people with Diabetic Wound, run by The First Affiliated Hospital of University of South China at 1 site in China.
Trial summary
This clinical study is a prospective, randomized, double-blind, positive-controlled, parallel study. Subjects who sign study informed consent (ICF) approved by Ethics Committee (EC) and meet all of the inclusion criteria and none of the exclusion criteria are eligible to enter the study.This clinical study is expected… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Wound
- What is being tested?
- GAT@F nanoenzyme hydrogel complex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Apr 2025
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily participate in this clinical study and sign informed consent;
- Subjects aged 18-80 years (including boundary values), male or female;
- Participants must meet the following criteria to participate in the study:
- Female subjects:
- Nonfertile (biologically incapable of becoming pregnant, including women who have gone through menopause for more than 2 years)
- Be potentially fertile, have a negative pregnancy test result, and agree to adhere to the correct use of an acceptable and effective contraceptive method during the study period
- Male subjects:
- An effective form of contraception or an effective form of contraception by a partner of the opposite sex must be used during the period of participation in this clinical trial 4)The clinical manifestations of the patient can meet the diagnostic criteria of diabetes; 5)There was at least 1 month of unhealed wounds before joining the clinical trial; 6)The patient's blood glucose was controlled at fasting blood glucose < 8mmol/L and at 2 hours after meal blood glucose < 11.1mmol/L; 7)Diabetic wounds meet Wagner grades 1 to 2; 8)Diabetic wounds conform to IDSA/IWGDF grade ≤2; 9)Diabetic wounds conform to the Wlfl evaluation system rating ≤2; 10)The size of the wound area is between 9cm2 and 100cm2; 11)There was a history of surgical dressing change or a desire for surgical intervention within 1 month before the visit; 12)In the investigators' judgment, subjects were willing and able to adjust the current diabetic wound treatment regimen as required; 13)Subjects must be willing to complete all visit assessments as required by the study protocol.
Who cannot join
- Participants in this clinical trial will not be enrolled if they meet any of the following criteria:
- The subject had any condition that required treatment or that the investigator felt might interfere with the study parameters, including aortitis, deep vein thrombosis, arterial thromboembolism, thromboangiitis obliterans, and varicose veins of the lower extremity; Patients with spinal cord injury and syringomyelia;
- Patients who have been diagnosed with chronic wounds caused by autoimmune diseases such as Becset's disease, psoriasis, or pemphigus, or who have used immunosuppressive biologics or immunosuppressants within the last 12 months or are expected to use them during the study period;
- Any lower extremity vascular and related surgery is planned during the study period;
- Women who are pregnant or breastfeeding or plan to become pregnant during the study period, or women who are fertile but not using effective contraception;
- Patients with pacemakers, severe weakness of heart, lung and kidney function, malignant tumors, various bleeding disorders, acute infectious diseases, high fever, high fever disease, cardiac surgery after recovery, or have a medical condition that the physician believes may prevent the subject from participating in the study and follow-up;
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- The subject is allergic to the same dressing;
- Subjects had a history of alcohol and drug abuse;
- Subjects have significant medical conditions other than diabetic wounds (sepsis, tuberculosis, etc.), trauma, or other conditions that, in the investigator's judgment, would put them at risk for participating in the study, or would interfere with the study results, or would have an illness or condition that would affect their ability to participate in the study;
- Antibiotic dressings, silver ion dressings, zinc ion dressings and other dressings that interfered with the study results were used within 14 days prior to enrollment;
- The investigator, the assisting investigator, the investigator participating in the study, and the immediate family of the person mentioned above;
- History of mental illness, mental retardation, or other medical conditions that affect the validity of informed consent in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of University of South China
Hengyang, Hunan
About this study
Official title: A Prospective, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of a Hydrogel Containing Cascade Catalytic Enzymes in the Treatment of Diabetic Wounds
This clinical study is a prospective, randomized, double-blind, positive-controlled, parallel study. Subjects who sign study informed consent (ICF) approved by Ethics Committee (EC) and meet all of the inclusion criteria and none of the exclusion criteria are eligible to enter the study.This clinical study is expected to include 49 participants and treat patients with diabetic wounds.Each participant is expected to participate for about 3 months, including a 2-week screening period, a 2-week dressing period, and an 8-week safety follow-up period.
Successfully enrolled subjects will be randomly divided into one of the following treatment groups: (1)GAT@F nanoenzyme hydrogel complex dressing(2)Medical chitosan bio-gel dressing (3)Blank hydrogel dressing.
Diabetic wounds were treated with experimental dressing, and dressing was changed once a day for 14 consecutive days.Neither subjects nor investigators were informed of the treatment assignment.During treatment, the granulation coverage rate and wound healing rate of each group were evaluated at the second visit, the third visit and the fourth visit.Wounds were scored using Wagner grading scale, Wlfl grading scale and IDSA/IWGDF grading scale.The histological morphology, ROS, sugar content, IL-6 and TNF-α of the wound were quantitatively detected at the second and fifth visits, and the changes of the data results compared with baseline were evaluated.The tolerability (occurrence of local adverse events) and acceptability (ease of application and removal, adherence of the dressing to the wound bed, bleeding or pain during dressing removal) of the dressing were qualitatively assessed and recorded at the 2nd visit, 3rd visit, and 4th visit.The safety follow-up was conducted by telephone on the 30th and 60th day after the last treatment to collect safety information.
- Conditions
- Diabetic Wound
- Being tested
- GAT@F nanoenzyme hydrogel complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAT@F nanoenzyme hydrogel complexDrug
The wound condition was recorded by taking photos each time the dressing was changed. The diabetic wound was routinely treated with a dressing change, after which GAT@F nanoenzyme hydrogel complex was applied externally and a secondary dressing - medical surgical gauze was added. According to existing clinical data, it is recommended to use no more than 10ml per dressing change.
| Study group | Role | What they receive |
|---|---|---|
| GAT@F nanoenzyme hydrogel complex | Experimental | The glucose oxidase (GOx) and catalase (CAT) cascade systems have been included in the therapeutic system of diabetic wounds,with GOx primarily consumes glucose to create H2O2, while CAT further catalyzes H2O2 to provide sufficient oxygen.Natural enzymes have excellent cascade catalytic efficiency as well as biocompatibility. Hydrogels have high water content and cargo loading efficiency, as well as superior biocompatibility, making them popular in wound healing applications. Receives: Drug: GAT@F nanoenzyme hydrogel complex |
| Medical chitosan bio-gel dressing | Active comparator | The medical device database of the National Medical Products Administration (NMPA) was searched and the Medical chitosan bio-gel dressing (6S YinYu)(20182640080) was selected.
The positive control product used in this trial is based on the following points:
1. The properties of the test products are similar, and both the test products and the control products are hydrogel dosage forms;
2. In terms of the duration of therapeutic effect, both the experimental product and the control product could achieve the maintenance of therapeutic effect;
3. The control product is widely used by clinicians at this stage, and its clinical efficacy is relatively confirmed, with good clinical effect and safety, and it is one of the treatment products recognized by the industry for wound repair. Receives: Drug: GAT@F nanoenzyme hydrogel complex |
| Blank hydrogel dressing | Placebo comparator | Hydrogel dressings can maintain a moist environment at the wound site, which promotes cell migration and tissue regeneration, thus accelerating the healing process. Hydrogels have excellent absorption capabilities, helping to manage wound exudate and reduce the risk of infection by forming a physical barrier against bacteria and contaminants. Moreover, hydrogels are biocompatible and unlikely to cause allergic reactions or rejection. Their softness and flexibility enable them to conform to irregular wound surfaces, providing effective coverage and protection. Receives: Drug: GAT@F nanoenzyme hydrogel complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Granulation coverage
Wound granulation tissue coverage (%) = (granulation coverage area)/(total wound area) ×100%
Measured: 14 days
Secondary outcomes (8)
Wound healing rate
Wound healing rate (%) = (original wound area - current wound area)/(original wound area) ×100%
Measured: 14 days
Wagner rating Scale
Measured: 14 days
Wlfl rating Scale
Measured: 14 days
IDSA/IWGDF rating scale score
Measured: 14 days
Histopathological analysis score
Measured: 14 days
ROS quantitative detection value of wound tissue
Measured: 14 days
Quantitative measurement of sugar content in wound tissue
Measured: 14 days
Quantitative detection of IL-6 and TNF-α in wound tissue
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Apr 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic WoundStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of South China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492811
- Sponsor's protocol ID
- nhfy20240305
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of a Hydrogel Containing Cascade Catalytic Enzymes in the Treatment of Diabetic Wounds
- ClinicalTrials.gov ID
- NCT06492811
- Acronym / sponsor ID
- nhfy20240305
- Conditions
- Diabetic Wound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of South ChinaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 9 Jul 2024 (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.
This clinical study is a prospective, randomized, double-blind, positive-controlled, parallel study. Subjects who sign study informed consent (ICF) approved by Ethics Committee (EC) and meet all of the inclusion criteria and none of the exclusion criteria are eligible to enter the study.This clinical study is expected to include 49 participants and treat patients with diabetic wounds.Each participant is expected to participate for about 3 months, including a 2-week screening period, a 2-week dressing period, and an 8-week safety follow-up period.
Successfully enrolled subjects will be randomly divided into one of the following treatment groups: (1)GAT@F nanoenzyme hydrogel complex dressing(2)Medical chitosan bio-gel dressing (3)Blank hydrogel dressing.
Diabetic wounds were treated with experimental dressing, and dressing was changed once a day for 14 consecutive days.Neither subjects nor investigators were informed of the treatment assignment.During treatment, the granulation coverage rate and wound healing rate of each group were evaluated at the second visit, the third visit and the fourth visit.Wounds were scored using Wagner grading scale, Wlfl grading scale and IDSA/IWGDF grading scale.The histological morphology, ROS, sugar content, IL-6 and TNF-α of the wound were quantitatively detected at the second and fifth visits, and the changes of the data results compared with baseline were evaluated.The tolerability (occurrence of local adverse events) and acceptability (ease of application and removal, adherence of the dressing to the wound bed, bleeding or pain during dressing removal) of the dressing were qualitatively assessed and recorded at the 2nd visit, 3rd visit, and 4th visit.The safety follow-up was conducted by telephone on the 30th and 60th day after the last treatment to collect safety information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GAT@F nanoenzyme hydrogel complex | Experimental | Drug: GAT@F nanoenzyme hydrogel complexThe glucose oxidase (GOx) and catalase (CAT) cascade systems have been included in the therapeutic system of diabetic wounds,with GOx primarily consumes glucose to create H2O2, while CAT further catalyzes H2O2 to provide sufficient oxygen.Natural enzymes have excellent cascade catalytic efficiency as well as biocompatibility. Hydrogels have high water content and cargo loading efficiency, as well as superior biocompatibility, making them popular in wound healing applications. |
| Medical chitosan bio-gel dressing | Active comparator | Drug: GAT@F nanoenzyme hydrogel complexThe medical device database of the National Medical Products Administration (NMPA) was searched and the Medical chitosan bio-gel dressing (6S YinYu)(20182640080) was selected. The positive control product used in this trial is based on the following points: 1. The properties of the test products are similar, and both the test products and the control products are hydrogel dosage forms; 2. In terms of the duration of therapeutic effect, both the experimental product and the control product could achieve the maintenance of therapeutic effect; 3. The control product is widely used by clinicians at this stage, and its clinical efficacy is relatively confirmed, with good clinical effect and safety, and it is one of the treatment products recognized by the industry for wound repair. |
| Blank hydrogel dressing | Placebo comparator | Drug: GAT@F nanoenzyme hydrogel complexHydrogel dressings can maintain a moist environment at the wound site, which promotes cell migration and tissue regeneration, thus accelerating the healing process. Hydrogels have excellent absorption capabilities, helping to manage wound exudate and reduce the risk of infection by forming a physical barrier against bacteria and contaminants. Moreover, hydrogels are biocompatible and unlikely to cause allergic reactions or rejection. Their softness and flexibility enable them to conform to irregular wound surfaces, providing effective coverage and protection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects who voluntarily participate in this clinical study and sign informed consent;
- Subjects aged 18-80 years (including boundary values), male or female;
- Participants must meet the following criteria to participate in the study:
Key exclusion criteria (12 listed)
- Participants in this clinical trial will not be enrolled if they meet any of the following criteria:
- The subject had any condition that required treatment or that the investigator felt might interfere with the study parameters, including aortitis, deep vein thrombosis, arterial thromboembolism, thromboangiitis obliterans, and varicose veins of the lower extremity; Patients with spinal cord injury and syringomyelia;
- Patients who have been diagnosed with chronic wounds caused by autoimmune diseases such as Becset's disease, psoriasis, or pemphigus, or who have used immunosuppressive biologics or immunosuppressants within the last 12 months or are expected to use them during the study period;
- Any lower extremity vascular and related surgery is planned during the study period;
- Women who are pregnant or breastfeeding or plan to become pregnant during the study period, or women who are fertile but not using effective contraception;
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 |
|---|---|---|
| GAT@F nanoenzyme hydrogel complexThe wound condition was recorded by taking photos each time the dressing was changed. The diabetic wound was routinely treated with a dressing change, after which GAT@F nanoenzyme hydrogel complex was applied externally and a secondary dressing - medical surgical gauze was added. According to existing clinical data, it is recommended to use no more than 10ml per dressing change. | Drug | Blank hydrogel dressing, GAT@F nanoenzyme hydrogel complex, Medical chitosan bio-gel dressing |
Primary outcome
Granulation coverage
Time frame: 14 days
Wound granulation tissue coverage (%) = (granulation coverage area)/(total wound area) ×100%
8 secondary outcomes
Wound healing rate
Time frame: 14 days
Wagner rating Scale
Time frame: 14 days
Wlfl rating Scale
Time frame: 14 days
IDSA/IWGDF rating scale score
Time frame: 14 days
Histopathological analysis score
Time frame: 14 days
ROS quantitative detection value of wound tissue
Time frame: 14 days
Quantitative measurement of sugar content in wound tissue
Time frame: 14 days
Quantitative detection of IL-6 and TNF-α in wound tissue
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing GAT@F nanoenzyme hydrogel complex in people with Diabetic Wound, run by The First Affiliated Hospital of University of South China 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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Granulation coverage (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.