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Observation on the Clinical Efficacy of Gu Bu Tang Modification Combined with PPL in the Treatment of Heat Toxin-Induced Yin Deficiency Syndrome in Diabetic Foot Ulcer

Observation on the Clinical Efficacy of Gu Bu Tang Modification Combined with PPL in the Treatment of Heat Toxin-Induced Yin Deficiency Syndrome in Diabetic Foot Ulcer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000258
Enrollment
Unknown
Registered
2026-02-03
Start date
2025-06-06
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Heat-toxicity injuring yin syndrome diabetic foot ulcer

Interventions

Content Group A:Oral administration of modified Gu Bu Tang combined with endovascularoplasty of the plantar arterial arch in the affected limb to fully open the plantar arch.
Group C:Oral administration of Gu Bu Tang addition and subtraction, and revascularization of the popliteal artery in the affected limb (based on preoperative objective imaging, determined to be an unr
Group B:The affected limb underwent endovascularoplasty of the plantar arterial arch, successfully opening the entire plantar arch, without the use of traditional Chinese medicine.

Sponsors

Shandong University of Traditional Chinese Medicine Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Conform to the diagnostic criteria of heat-toxicity damaging yin in traditional Chinese medicine for gangrene; (2) Conform to the diagnostic criteria for diabetic foot in Western medicine; (3) Conform to the Wagner grading criteria for stages 2 to 4; (4) CTA confirms involvement of the anterior and/or posterior tibial arteries and the plantar arterial arch; (5) ABI = 0.5; (6) Patients with good compliance, capable of cooperating with treatment and observation.

Exclusion criteria

Exclusion criteria: (1) Patients with severe heart, liver, and kidney dysfunction; (2) Patients with malignant tumors; (3) Patients with coagulation system dysfunction and allergy to antiplatelet aggregation drugs; (4) Patients requiring amputation due to uncorrectable infections or those terminating treatment for various reasons; (5) Patients with poor blood sugar control (glycated hemoglobin >12.00%); (6) Pregnant, breastfeeding women, and special populations with mental disorders; (7) Patients who have allergic reactions or other adverse reactions to the Chinese medicine used.

Design outcomes

Primary

MeasureTime frame
Wound area;

Secondary

MeasureTime frame
Applied Behavior Analysis;Pain score;Blood flow filling status;Wagner grading;Diabetic Foot Quantitative Scoring in Traditional Chinese Medicine;

Countries

China

Contacts

Public ContactHao Qingzhi

Shandong University of Traditional Chinese Medicine Affiliated Hospital

15662416587@126.com15662416587

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026