An interventional study of Modified Simiao Yongan Decoction and Endovascular Therapy and Standard Care in Diabetic Foot Ulcer and Damp-Heat Toxins Accumulation Syndrome, sponsored by Chengdu University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Chengdu University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
This study evaluates the clinical efficacy and safety of a Modified Simiao Yongan Decoction when used alongside standard endovascular therapy and wound care for the treatment of diabetic foot ulcers. The trial focuses on patients presenting with the damp-heat toxins accumulation syndrome (Rutherford 4-5 or Wagner 2-4 classifications). Enrolling 120 participants, the study aims to observe the complete ulcer healing rate, limb salvage outcomes, and improvements in patient quality of life over a 6 to 24-month follow-up period.
This is a single-center, prospective, non-randomized, parallel-controlled cohort study designed to address the clinical challenge of delayed diabetic foot ulcer (DFU) healing despite upstream vascular recanalization. The study will enroll 120 patients, assigned to either a standard treatment control group or an experimental group. The control group will receive standard endovascular intervention, an anti-thrombotic regimen, and standard wound care. The experimental group will receive these same standard treatments plus a one-month regimen of Modified Simiao Yongan Decoction.
The study's primary endpoints evaluate Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE). Secondary clinical outcomes include the complete ulcer healing time, clinical-driven target lesion revascularization (CD-TLR), ankle-brachial index (ABI), transcutaneous oxygen pressure (TcPO2), and changes in Traditional Chinese Medicine syndrome scores and VascuQoL-6 scores.
In addition to clinical metrics, the research investigates the underlying molecular mechanisms, specifically how the intervention regulates the vascular-immune microenvironment through the HIF-1α/VEGF pathway and macrophage polarization to promote angiogenesis and tissue repair. Statistical analyses will employ Inverse Probability of Treatment Weighting (IPTW) to balance baseline characteristics and the Fine-Gray competing risk model for robust outcome evaluation.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Chengdu University of Traditional Chinese Medicine is the lead sponsor of 59 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will undergo standard endovascular intervention, receive a standardized antithrombotic regimen, and undergo standard wound care. In addition, they will receive a 1-month course of Modified Simiao Yongan Decoction granules.
Drug: Modified Simiao Yongan Decoction · Procedure: Endovascular Therapy and Standard Care
Participants in this group will undergo standard endovascular intervention, receive a standardized antithrombotic regimen, and undergo standard wound care without the addition of the herbal granules.
Procedure: Endovascular Therapy and Standard Care
A 1-month course of oral granules administered following standard endovascular revascularization.
Standard revascularization via endovascular intervention, supplemented with a standardized post-operative antithrombotic regimen. Standard care also includes strict blood glucose control, infection management, wound decompression, regular dressing changes, and necessary nutritional support.
Incidence of Major Adverse Limb Events (MALE)
A composite endpoint defined as major amputation of vascular etiology or clinical-driven target lesion revascularization (CD-TLR)
Time frame: Up to 24 months post-operatively
Incidence of Major Adverse Cardiovascular Events (MACE) and Major Bleeding.
A composite endpoint defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke, alongside any major bleeding events requiring medical intervention.
Time frame: Up to 24 months post-operatively
Complete Ulcer Healing Rate and Time
The rate and total time required for the target diabetic foot ulcer to completely heal.
Time frame: Assessed at 1, 3, 6, and 12 months post-operatively.
Ankle-Brachial Index (ABI)
The ankle-brachial index (ABI) of the target limb will be measured to assess lower-extremity macrovascular perfusion. ABI is calculated as the ratio of ankle systolic blood pressure to brachial systolic blood pressure.
Time frame: Baseline and 1, 3, 6, and 12 months post-operatively.
Transcutaneous Oxygen Pressure (TcPO2)
Transcutaneous oxygen pressure (TcPO2) of the target limb will be measured in mmHg to assess local tissue oxygenation and microcirculatory perfusion.
Time frame: Baseline and 1, 3, 6, and 12 months post-operatively.
Traditional Chinese Medicine Damp-Heat Toxins Accumulation Syndrome Score
The Traditional Chinese Medicine Damp-Heat Toxin Accumulation Syndrome Score is used to assess the severity of syndrome-related symptoms and signs. The scale consists of eight items, including four primary symptoms and four secondary symptoms. Each item is scored from 0 to 3, where 0 indicates absence of the symptom and 3 indicates severe manifestations. The total score ranges from 0 to 24, with higher scores indicating greater syndrome severity and therefore a worse outcome.
Time frame: Assessed at 1, 3, 6, and 12 months post-operatively.
Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score
The Vascular Quality of Life Questionnaire-6 (VascuQoL-6) is a six-item disease-specific questionnaire used to assess health-related quality of life in patients with peripheral arterial disease. Each item is scored from 1 to 4, resulting in a total score ranging from 6 to 24. Higher scores indicate better health-related quality of life and therefore a better outcome.
Time frame: Assessed at 1, 3, 6, and 12 months post-operatively.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.
Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 18 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Chengdu University of Traditional Chinese Medicine