Diabetic Foot UlcerNCT07808502
Clinical Efficacy of Modified Simiao Yongan Decoction and Endovascular Therapy for Diabetic Foot Ulcers
A study testing Modified Simiao Yongan Decoction in people with Diabetic Foot Ulcer and Damp-Heat Toxins Accumulation Syndrome, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Damp-Heat Toxins Accumulation Syndrome
- What is being tested?
- Modified Simiao Yongan Decoction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with a Diabetic Foot Ulcer (DFU).
- Assessed as Rutherford classification 4-5 or Wagner classification 2-4.
- Successfully received lower extremity endovascular intervention.
- Meets the Traditional Chinese Medicine diagnostic criteria for "Damp-Heat Toxins Accumulation Syndrome". Patients must exhibit at least two primary symptoms (red/swollen/hot/painful limb, high exudate or purulent secretion with foul odor, dark purple wound/necrotic tissue, elevated local skin temperature) and at least one secondary symptom (dry mouth/bitter taste, dry stool, red tongue with yellow greasy coating, rapid/string-taut pulse).
Who cannot join
- Patients with severe, uncontrolled life-threatening systemic diseases, such as severe heart failure (NYHA class III-IV), severe hepatic or renal dysfunction, or active malignancy.
- Patients with active systemic sepsis, extensive gangrene, or severe osteomyelitis requiring immediate major amputation of the target limb.
- Patients with known allergies, hypersensitivity, or severe adverse reactions to any of the herbal components of the Modified Simiao Yongan Decoction.
- Patients with severe gastrointestinal disorders that would significantly impair the absorption of oral medications.
- Women who are pregnant, planning to become pregnant, or currently lactating.
- Patients with severe cognitive impairment, psychiatric disorders, or poor compliance that would prevent them from providing informed consent or adhering to the 24-month follow-up schedule.
- Patients currently participating in, or who have participated in within the last 30 days, another interventional clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
Chunshui He, PhD, +86 18981885601, chunshui_he@163.com
About this study
Official title: Clinical Efficacy and Mechanism of Modified Simiao Yongan Decoction Combined With Endovascular Therapy for Diabetic Foot Ulcers (Damp-Heat Toxins Accumulation Syndrome) Based on the Vascular-Immune Microenvironment
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.
Read the detailed description
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.
- Being tested
- Modified Simiao Yongan Decoction, Endovascular Therapy and Standard Care
- Keywords
- Diabetic Foot Ulcer, Endovascular Therapy, Traditional Chinese Medicine, Vascular-Immune Microenvironment, Macrophage Polarization, Modified Simiao Yongan Decoction
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Simiao Yongan DecoctionDrug
A 1-month course of oral granules administered following standard endovascular revascularization.
Endovascular Therapy and Standard CareProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Drug: Modified Simiao Yongan Decoction; Procedure: Endovascular Therapy and Standard Care |
| Standard Treatment Control Group | Active comparator | 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. Receives: Procedure: Endovascular Therapy and Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Up to 24 months post-operatively
Secondary outcomes (5)
Complete Ulcer Healing Rate and Time
The rate and total time required for the target diabetic foot ulcer to completely heal.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at 1, 3, 6, and 12 months post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, non-randomized, parallel-controlled cohort study
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunshui He, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808502
- Sponsor's protocol ID
- ChengduUTCMvs10
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Mechanism of Modified Simiao Yongan Decoction Combined With Endovascular Therapy for Diabetic Foot Ulcers (Damp-Heat Toxins Accumulation Syndrome) Based on the Vascular-Immune Microenvironment
- ClinicalTrials.gov ID
- NCT07808502
- Acronym / sponsor ID
- ChengduUTCMvs10
- Keywords
- Diabetic Foot Ulcer, Endovascular Therapy, Traditional Chinese Medicine, Vascular-Immune Microenvironment, Macrophage Polarization, Modified Simiao Yongan Decoction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, prospective, non-randomized, parallel-controlled cohort study
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Modified Simiao Yongan Decoction, Procedure: Endovascular Therapy and Standard CareParticipants 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. |
| Standard Treatment Control Group | Active comparator | Procedure: Endovascular Therapy and Standard CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with a Diabetic Foot Ulcer (DFU).
- Assessed as Rutherford classification 4-5 or Wagner classification 2-4.
- Successfully received lower extremity endovascular intervention.
- Meets the Traditional Chinese Medicine diagnostic criteria for "Damp-Heat Toxins Accumulation Syndrome". Patients must exhibit at least two primary symptoms (red/swollen/hot/painful limb, high exudate or purulent secretion with foul odor, dark purple wound/necrotic tissue, elevated local skin temperature) and at least one secondary symptom (dry mouth/bitter taste, dry stool, red tongue with yellow greasy coating, rapid/string-taut pulse).
Key exclusion criteria (7 listed)
- Patients with severe, uncontrolled life-threatening systemic diseases, such as severe heart failure (NYHA class III-IV), severe hepatic or renal dysfunction, or active malignancy.
- Patients with active systemic sepsis, extensive gangrene, or severe osteomyelitis requiring immediate major amputation of the target limb.
- Patients with known allergies, hypersensitivity, or severe adverse reactions to any of the herbal components of the Modified Simiao Yongan Decoction.
- Patients with severe gastrointestinal disorders that would significantly impair the absorption of oral medications.
- Women who are pregnant, planning to become pregnant, or currently lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Simiao Yongan DecoctionA 1-month course of oral granules administered following standard endovascular revascularization. | Drug | Experimental Group |
| Endovascular Therapy and Standard CareStandard 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. | Procedure or surgery | Experimental Group, Standard Treatment Control Group |
Primary outcome
Incidence of Major Adverse Limb Events (MALE)
Time frame: Up to 24 months post-operatively
A composite endpoint defined as major amputation of vascular etiology or clinical-driven target lesion revascularization (CD-TLR)
Incidence of Major Adverse Cardiovascular Events (MACE) and Major Bleeding.
Time frame: Up to 24 months post-operatively
A composite endpoint defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke, alongside any major bleeding events requiring medical intervention.
5 secondary outcomes
Complete Ulcer Healing Rate and Time
Time frame: Assessed at 1, 3, 6, and 12 months post-operatively.
Ankle-Brachial Index (ABI)
Time frame: Baseline and 1, 3, 6, and 12 months post-operatively.
Transcutaneous Oxygen Pressure (TcPO2)
Time frame: Baseline and 1, 3, 6, and 12 months post-operatively.
Traditional Chinese Medicine Damp-Heat Toxins Accumulation Syndrome Score
Time frame: Assessed at 1, 3, 6, and 12 months post-operatively.
Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score
Time frame: Assessed at 1, 3, 6, and 12 months post-operatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Simiao Yongan Decoction in people with Diabetic Foot Ulcer and Damp-Heat Toxins Accumulation Syndrome, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunshui He, PhD (+86 18981885601, chunshui_he@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Limb Events (MALE) (time frame: Up to 24 months post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.