Clinical trial NCT06492811: Efficacy and Safety of a Hydrogel Containing Cascade Catalytic Enzymes in the Treatment of Diabetic Wounds
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Diabetic Wound
Lead sponsor: The First Affiliated Hospital of University of South China
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Subjects who voluntarily participate in this clinical study and sign informed consent;
2. Subjects aged 18-80 years (including boundary values), male or female;
3. Participants must meet the following criteria to participate in the study:

   1. 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
   2. 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.

Exclusion Criteria:

Participants in this clinical trial will not be enrolled if they meet any of the following criteria:

1. 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;
2. 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;
3. Any lower extremity vascular and related surgery is planned during the study period;
4. 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;
5. 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;
6. The subject is allergic to the same dressing;
7. Subjects had a history of alcohol and drug abuse;
8. 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;
9. 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;
10. The investigator, the assisting investigator, the investigator participating in the study, and the immediate family of the person mentioned above;
11. History of mental illness, mental retardation, or other medical conditions that affect the validity of informed consent in this study.

Primary outcomes:
measure: Granulation coverage
timeFrame: 14 days
Secondary outcomes:
measure: Wound healing rate
timeFrame: 14 days
measure: Wagner rating Scale
timeFrame: 14 days
measure: Wlfl rating Scale
timeFrame: 14 days
measure: IDSA/IWGDF rating scale score
timeFrame: 14 days
measure: Histopathological analysis score
timeFrame: 14 days
measure: ROS quantitative detection value of wound tissue
timeFrame: 14 days
measure: Quantitative measurement of sugar content in wound tissue
timeFrame: 14 days
measure: Quantitative detection of IL-6 and TNF-α in wound tissue
timeFrame: 14 days
Other outcomes:
Locations:
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
Study officials:
References: