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Efficacy and Safety of Antibiotic-loaded Calcium Sulfate/Bone Cement Combined with Transverse Bone Transposition (TTT) for the Treatment of Wagner Grade 3-4 Diabetic Foot Ulcers: A Randomized Controlled Trial

Efficacy and Safety of Antibiotic-loaded Calcium Sulfate/Bone Cement Combined with Transverse Bone Transposition (TTT) for the Treatment of Wagner Grade 3-4 Diabetic Foot Ulcers: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126371
Enrollment
Unknown
Registered
2026-06-08
Start date
2026-07-05
Completion date
Unknown
Last updated
2026-06-15

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

Conditions

Wagner Grade 3-4 Diabetic Foot Ulcers

Interventions

intervention group :Received antibiotic-loaded calcium sulfate/cement combined with Transverse Bone Transposition (TTT) treatment.
control group:Participants in the control group will receive standard care

Sponsors

Taizhou Hospital of Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. adults aged 18 to 80 years with a confirmed diagnosis of diabetes mellitus; 2. presence of a Wagner grade 3 or 4 DFU that has failed to respond to standard conservative treatment; 3. foot ulcer area greater than 1 cm^2 with a duration of non-healing exceeding 6 weeks; 4. relatively stable glycemic control, defined as glycated hemoglobin (HbA1c) <= 8%; 5. ability to understand the study procedures and provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1. severe comorbid conditions, such as significant cardiac disease or severe hepatic or renal dysfunction; 2. severe lower-extremity ischemia or irreversible peripheral arterial disease; 3. prior foot surgery or the presence of foot malignancy; 4. pregnancy or breastfeeding; 5. inability to comply with the study protocol or complete effective follow-up.

Design outcomes

Primary

MeasureTime frame
Ulcer healing rate;Postoperative complication rates;

Secondary

MeasureTime frame
Pain;quality-of-life;Imaging assessments;Patient adherence;

Countries

China

Contacts

Public ContactLiao Mirong

Taizhou Hospital of Zhejiang Province

liaomr@enzemed.com+86 137 3620 0993

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026