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Study on dipeptidyl peptidase 4 inhibitor for diabetic foot ulcer

Study on dipeptidyl peptidase 4 inhibitor for diabetic foot ulcer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029230
Enrollment
Unknown
Registered
2020-01-19
Start date
2020-01-31
Completion date
Unknown
Last updated
2020-01-20

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:Sieglitine combined with standard treatment
control group:standard treatment

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Part I: changes in the number of peripheral blood stem cells in patients with diabetes mellitus, diabetes mellitus combined with lower limb artery disease and diabetic foot disease 1. Inclusion criteria 1) inclusion criteria of the normal control group: healthy volunteers with normal blood glucose, blood lipid, blood pressure and Body Mass Index (BMI) were selected from the physical examination center of west China hospital of sichuan university. 2) inclusion criteria for diabetes: patients who had been diagnosed with type 2 diabetes without peripheral vascular disease and had not used ddp-4 inhibitors within 6 months were selected from west China hospital of sichuan university. The diagnostic criteria for type 2 diabetes were based on the diagnostic criteria of ADA in 2012. 3) grouping criteria for diabetes combined with lower limb artery lesions: patients with type 2 diabetes combined with lower limb artery lesions were selected from west China hospital of sichuan university, and had not used DDP-4 inhibitor within 6 months. The diagnostic criteria for lower limb artery lesions were Ankle Brachial Index =0.9. 4) inclusion criteria for diabetic foot disease: patients with diabetic foot ulcer were selected from west China hospital of sichuan university. The ulcer was below the ankle joint, Wagner grade 2-4, treated with insulin or at least one oral hypoglycemic drug, and ddp-4 inhibitor was not used within 6 months. 5) they are all between 40 and 80 years old. Part II: randomized controlled trial of dpp-4 inhibitors in the treatment of diabetic foot ulcers Inclusion criteria: same as part I diabetic foot group.

Exclusion criteria

Exclusion criteria: Combined with serious primary diseases of cardiovascular and cerebrovascular, lung, liver, kidney and hematopoietic system, or serious diseases that affect their survival, such as tumor or AIDS;Uncontrolled infection;Treatment with recombinant or autogenous growth factor products;Prepare pregnant, pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
ulcer area;number of CD34+ stem cells in peripheral blood;

Secondary

MeasureTime frame
SDF-1a;CD34 of tissue;CXC4 of tissue;Vascular Endothelial Growth Factor;Vascular Endothelial Growth Factor of tissue;

Countries

China

Contacts

Public ContactXingwu Ran

West China Hospital, Sichuan University

ranxingwu@163.com+86 18980601305

Outcome results

None listed

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