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Effectiveness and safety of topical estrogen combined with topical growth factor therapy for diabetic foot ulcers: cohort prospective clinical study

Effectiveness and safety of topical estrogen combined with topical growth factor therapy for diabetic foot ulcers: cohort prospective clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103516
Enrollment
Unknown
Registered
2025-05-30
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Diabetic foot ulcers

Interventions

Control group:Standard treatment for diabetic foot
Topical estrogen group:Topical estrogen+Standard treatment for diabetic foot
FGF group:Topical FGF+Standard treatment for diabetic foot
Topical estrogen+topical FGF group:Topical estrogen+topical FGF+Standard treatment for diabetic foot

Sponsors

Wenzhou Medical University First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Type 1 or type 2 diabetes that meets the 1999 WHO diagnostic criteria for diabetes (2) Wagner grade 1-4 diabetic foot ulcers (3) Age >=18 years old but =0.3 but =1 cm2 and <= 60 cm2 (6) The subjects understood the content of this study and agreed to participate (7) Female

Exclusion criteria

Exclusion criteria: (1)Hemoglobin =180mmHg or diastolic blood pressure>=110mmHg (3) Confirmed or suspected breast cancer, or a previous history of breast cancer (4) Newly diagnosed or suspected estrogen-dependent organisms (such as endometrial cancer, endometrial hyperplasia) (5) Active or previously diagnosed venous thromboembolism (such as deep vein thrombosis, pulmonary embolism) (6) Active or recently suffering from arterial thromboembolic diseases (such as cerebral infarction). Myocardial infarction (7) Poor liver function or liver diseases (8) Patients who have suffered semi-blindness, total blindness or diplopia due to ocular vascular diseases (9) There are concurrent malignant tumors that may affect life expectancy. (10) Creatinine > 200µmol/L or creatinine clearance rate < 30 ml/min (11) Confirmed or suspected pregnancy (12) Undiagnosed abnormal bleeding of the reproductive tract

Design outcomes

Primary

MeasureTime frame
The complete skin healing rate ;

Secondary

MeasureTime frame
Percentage of patients with >75% granulation tissue formation at 2, 4, and 8 weeks;Percentage of patients with complete skin healing at week 20;Time required for granulation tissue to form >75%;The time required to achieve complete skin healing;Rates of major and minor amputations and recurrence;

Countries

China

Contacts

Public ContactHong Jing

Wenzhou Medical University First Affiliated Hospital

hongjing316@163.com+86 138 5889 2882

Outcome results

None listed

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