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Clinical observation and mechanism study of Huangqi Shengji Powder on chronic refractory wounds of diabetes with Qi deficiency and blood stasis

Clinical observation and mechanism study of Huangqi Shengji Powder on chronic refractory wounds of diabetes with Qi deficiency and blood stasis

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072235
Enrollment
Unknown
Registered
2023-06-07
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes is chronic and difficult to heal wounds

Interventions

one:Huangqi Shengji Powder
two:Fusidic acid ointment was applied externally and the wound was irradiated with red light for 20 minutes

Sponsors

The First Affiliated Hospital of Zhejiang University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ?Obtain the patient's consent and sign the informed consent. ?Met the diagnostic criteria for chronic refractory diabetic ulcer: all patients met the diagnostic criteria for diabetes mellitus, and the ulcer was Wagner grade I or above. Wagner classification: Grade 1: ulcers on the skin surface of the foot, and the lesions did not spread to deep tissues, with neurotic ulcers as the prominent manifestations. Grade 2: Infection invading deep muscle tissue, often accompanied by soft tissue infection, but no osteomyelitis or deep abscess; Grade 3: tendon and ligament tissue destruction, accompanied by deep abscess or osteomyelitis, bone destruction is not obvious; Grade 4: The infection has caused bone destruction, characterized by ischemic ulceration, dry or wet gangrene locally or in specific parts of the foot; Grade 5: The infection affects most or all of the foot, and severe dry or wet gangrene occurs. ?Conforms to the deficiency of Yin and blood stasis type certificate ulcers TCM diagnostic criteria: foot numbness or pain, skin cool, wound gray color and soring is amazing and rotting flesh not to take off, or new meat is not born, pus thin, bloody water, bipedal weakness, god fatigue, sleepiness, tired, or ecchymosis tongue an, sink of arteries and veins thin or heavy fine dry or generation. ?In line with the age of 18-80 years old, regardless of gender. ?The results of blood routine, urine routine, liver and kidney function were within the normal range.

Exclusion criteria

Exclusion criteria: ?Complicated with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases, tumor patients, mental patients; ?Patients with severe infection and critical illness; ?Pregnant and lactating women; ?Those who are known to be allergic to the experimental drug ingredients; ?It is participating in other clinical investigators; ?Other cases that do not meet the inclusion criteria; ?Poor compliance.

Design outcomes

Primary

MeasureTime frame
Changes in wound area;

Secondary

MeasureTime frame
Degree of swelling;Exudate volume;

Countries

China

Contacts

Public ContactCao Yi

The First Affiliated Hospital of Zhejiang University of Chinese Medicine

caoyi1965@163.com+86 135 8888 7388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026