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Randomized controlled study of bone cement and sealing negative pressure drainage dressing to promote diabetic foot wound healing

Randomized controlled study of bone cement and sealing negative pressure drainage dressing to promote diabetic foot wound healing

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043988
Enrollment
Unknown
Registered
2021-03-06
Start date
2021-03-02
Completion date
Unknown
Last updated
2021-07-12

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

Conditions

Diabetic foot

Interventions

Experimental group:Antibiotic bone cement material covered the wound
The control group:Negative pressure adjuvant therapy system material covered the wound

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 - 70 years, male or female; 2. Diagnosed with type 2 diabetes (diabetes inclusion criteria were based on the diabetes diagnostic criteria proposed by WHO Diabetes Expert Committee in 2005); 3. Conformed to the diagnosis of diabetic foot and Wagner grade (grade 2-3); Attachment: Wagner classification: 0 level (complete skin), I level (superficial ulcer), II level (deep ulcer consolidated soft tissue infection), III level (deep ulcer And abscess or osteomyelitis, IV level (part of the foot gangrene), V level (full foot gangrene bad); 4. No serious complications or other serious diseases (such as severe liver and kidney insufficiency, sepsis, etc.), and no absolute surgical contraindication; 5. Patients were informed and voluntarily participated in this study.

Exclusion criteria

Exclusion criteria: 1. Uncontrollable hyperglycemia (such as HbA1c >12.0%), diabetic ketoacidosis, non-ketoosmotic coma; 2. Complicated with malignant tumor; 3. Pregnant or lactating women; 4. Other diseases or mental illnesses that researchers think may limit efficacy evaluation or patient follow-up and are difficult to cooperate with the successful completion of the study; 5. Patients with serious uncontrolled diseases or systemic acute infection or with other serious organ diseases such as liver, kidney, heart, lung and brain diseases; 6. Those considered inappropriate by researchers; 7. Those who had participated in other clinical trials in the three months before the experiment.

Design outcomes

Primary

MeasureTime frame
The percentage of granulation wound area of diabetic foot;

Countries

China

Contacts

Public ContactZairong wei

Affiliated Hospital of Zunyi Medical University

188116999@qq.com+86 15208660008

Outcome results

None listed

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