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Can a traditional herbal mix save limbs from diabetic ulcers?

NCT ID NCT07808502

Disease control Sponsor: Chengdu University of Traditional Chinese Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether adding a modified herbal decoction, called Simiao Yongan, to standard care helps heal diabetic foot ulcers and prevent major amputations. The study enrolls 120 people with diabetic foot ulcers who have already had a procedure to restore blood flow to the leg. Participants receive either the herbal granules or a placebo for one month, alongside standard wound care and blood sugar control. Researchers will track ulcer healing, limb salvage, and quality of life over up to two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Modified Simiao Yongan Decoction, an oral herbal granule
What this could lead to
If it works, adding this herbal decoction to standard care could improve ulcer healing and reduce the need for major amputation in people with diabetic foot ulcers.
What could go wrong
This is an early-stage study with a modest number of participants, and the herbal formula may not add benefit beyond standard care. Risks include potential herb-drug interactions and side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Damp-heat toxins accumulation syndrome Diabetic foot ulcer

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan, 610075, China

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