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Evaluation of the effect of microenvironmental pH adjustment on wound rehabilitation of diabetic foot ulcers

Evaluation of the effect of microenvironmental pH adjustment on wound rehabilitation of diabetic foot ulcers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082390
Enrollment
Unknown
Registered
2024-03-27
Start date
2023-03-10
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Diabetic foot ulcers

Interventions

Intervention group:Adjustment measures of wound pH value
Control group:Conventional wound care for DFU patients

Sponsors

Huadong Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: ?Age =18 years old; ? Meet the diagnostic criteria of diabetic foot in the "Chinese Guidelines for the diagnosis and Treatment of diabetic foot"; ? Grade 2-4 according to Wagner classification of diabetic foot; ? Doppler ultrasound examination of at least one intact foot artery with good pulse or transcutaneous oxygen pressure =30 mmHg; ?Those who volunteered to participate in the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: ?The ulcer is above the ankle joint or, although it is below the ankle joint, it is complicated with serious and life-threatening infection requiring amputation; ? Patients with concurrent diseases that may affect the healing of DFU, such as tumor, osteomyelitis, vasculitis, connective tissue disease, immune system disorders, etc. Severe liver dysfunction, end-stage renal disease dialysis; Severe lower extremity vascular disease; Severe important organ dysfunction; ? Allergic or intolerant to acidic cleaning solution components; ? Cognitive dysfunction, depression and other mental disorders; ? Individuals who have participated in other clinical studies within the first three months of the study.

Design outcomes

Primary

MeasureTime frame
Reduction rate of wound area;

Secondary

MeasureTime frame
Wound healing rate;Granular tissue coverage rate;PUSH rating scale scoring;PH value of wound exudate;VAS;

Countries

China

Contacts

Public ContactJiaojiao Bai

Huadong Hospital Affiliated to Fudan University

974696684@qq.com+86 166 2167 0630

Outcome results

None listed

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