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Diabetic FootEarly Phase 1NCT06487117

The Efficacy and Safety Assessment of Huafu Shengji Ointment in Patients With Diabetic Foot of Qi Deficiency and Blood Stasis Syndrome

A Early Phase 1 study testing Huafu Shengji Ointment and ethacridine lactate solution in people with Diabetic Foot, run by Beijing Daxing District Hospital of Integrated Chinese and Western Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Diabetic foot ulcers, as a complication of diabetes with high disability and mortality rates, have become a significant global healthcare burden and medical challenge worldwide. The clinical situation of chronic non-healing ulcers leading to repeated amputations has not yet been resolved. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Diabetic Foot
What is being tested?
Huafu Shengji Ointment and ethacridine lactate solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Sep 2024to Dec 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

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 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -
  • Patients who meet the following criteria will be included:
  • Patients who meet the diagnostic criteria for diabetic foot and have a Wagner grade of 1-5.
  • It is in line with the syndrome type of qi deficiency and blood stasis in traditional Chinese medicine.
  • Age between 35 and 80 years
  • The patient had no serious cardiac, liver, renal insufficiency or other systemic infections.
  • No hereditary or infectious diseases, no malignant tumors, and no severe malnutrition in patients.
  • Have understood the treatment modality and voluntarily signed the informed consent form.

Who cannot join

  • -
  • Patients who meet any of the following criteria will be excluded:
  • Patients who experience severe allergic reactions to the experimental medication and cannot undergo treatment.
  • Patients with poorly controlled serious conditions such as diabetic ketoacidosis, ketoacidosis, or diseases of the liver and kidneys.
  • Patients with psychiatric disorders or severe depression.
  • Women who are pregnant or breastfeeding.
  • Patients with severe organic tumors.

About this study

Official title: The Efficacy and Safety Assessment of Huafu Shengji Ointment in Patients With Diabetic Foot of Qi Deficiency and Blood Stasis Syndrome: A Study Protocol for a Randomized Controlled Trial

Diabetic foot ulcers, as a complication of diabetes with high disability and mortality rates, have become a significant global healthcare burden and medical challenge worldwide. The clinical situation of chronic non-healing ulcers leading to repeated amputations has not yet been resolved. In preliminary clinical practice, Huafu Shengji Ointment has been shown to significantly improve the complete healing rate of ulcer wounds. This study aims to further comprehensively evaluate the therapeutic effects of Huafu Shengji Ointment and provide high-quality evidence.

Conditions
Diabetic Foot
Being tested
Huafu Shengji Ointment, ethacridine lactate solution
Keywords
Diabetic Foot Ulcer, Huafu Shengji Ointment, Qi Deficiency and Blood Stasis Syndrome, Randomized Controlled Trial
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Huafu Shengji OintmentDrug

    Huafu Shengji Ointment

    1. The experimental group received conventional medical treatment: diabetes-related knowledge education, blood sugar control, blood pressure reduction, blood lipid regulation, antiplatelet drugs, vasodilation, nerve nutrition, and the use of antibiotics.
    2. The experimental group receive local debridement: iodophor disinfection, saline cleaning, removal of necrotic tissue, and wound exposure.
    3. After debridement, Huafu Shengji Ointment is applied topically with a coverage thickness of 1mm, followed by sterile gauze dressing. The dressing is changed every other day. The treatment period is 4-8 weeks.

  • ethacridine lactate solutionDrug

    ethacridine lactate solution

    1. The control group received conventional medical treatment: diabetes-related knowledge education, blood sugar control, blood pressure reduction, blood lipid regulation, antiplatelet drugs, vasodilation, nerve nutrition, and the use of antibiotics.
    2. The control group receive local debridement: iodophor disinfection, saline cleaning, removal of necrotic tissue, and wound exposure.
    3. After debridement, the wound is cleaned and disinfected with ethacridine lactate solution, then covered and dressed with sterile gauze. The dressing is changed every other day. The treatment period is 4-8 weeks.
Study groups in NCT06487117
Study groupRoleWhat they receive
Huafu Shengji OintmentExperimentalAfter debridement, Huafu Shengji Ointment is applied topically with a coverage thickness of 1mm, followed by sterile gauze dressing. The dressing is changed every other day. The treatment period is 4-8 weeks.
Receives: Drug: Huafu Shengji Ointment
ethacridine lactate solutionActive comparatorAfter debridement, the wound is cleaned and disinfected with ethacridine lactate solution, then covered and dressed with sterile gauze. The dressing is changed every other day. The treatment period is 4-8 weeks.
Receives: Drug: ethacridine lactate solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ulcer area

    Method of measuring ulcer area: Sterile transparent dressings are used to trace the edges of the ulcer, digital cameras are used to capture the images, and ImageJ is utilized for analysis and processing.

    Measured: Measured once a week, for a total of 8 weeks.

  2. granulation tissue coverage

    Granulation tissue area coverage rate = (Area of the wound covered by granulation tissue [mm^2]) / (Total wound area [mm^2]) × 100%

    Measured: Measured once a week, for a total of 8 weeks.

  3. ulcer volume

    Ulcer volume measurement method: After debridement is completed, the wound surface is dried with a dry cotton ball. Sterile saline is injected into the ulcer cavity using a sterilized syringe until the liquid level is flush with the skin. When the ulcer is a fistula, one end of the fistula is sealed with sterile transparent film, and then saline is injected. The volume of the injected saline is equivalent to the volume of the ulcer.

    Measured: Measured once a week, for a total of 8 weeks.

  4. the time of complete wound healing

    Digital cameras capture images, documenting the process of wound from the ulcerative state to the complete in situ healing of the skin tissue.

    Measured: complete wound healing (assessed up to 8 weeks)

Secondary outcomes (9)

  1. the skin temperature around the wound

    0 Normal

    1. Intermittently feels cold
    2. Persistently cold, but can be relieved with warming measures
    3. Persistently cold, and cannot be relieved with warming measures
    4. Even with stronger warming measures than usual in a 20°C environment, still feels cold.

    Measured: Measured once a week, for a total of 8 weeks.

  2. the degree of pain

    0 No pain

    1. Pain occurs with activity or exertion
    2. Intermittent pain at rest
    3. Persistent pain at rest, but tolerable
    4. Severe persistent pain, sleepless nights, and pain relief requires analgesics

    Measured: Measured once a week, for a total of 8 weeks.

  3. skin color

    0 Normal skin color

    1. Intermittently pale skin
    2. Persistently pale skin
    3. Skin appears purplish-cyanotic
    4. Skin appears purplish-black or black

    Measured: Measured once a week, for a total of 8 weeks.

  4. the extent of wound exudate

    Covered with a 10 cm × 10 cm single-layer sterile gauze, scored based on the number of layers of gauze soaked through by exudate over 24 hours 0 1 layer

    1. 2 layers
    2. 3 layers
    3. 4 layers
    4. ≥ 5 layers

    Measured: Measured once a week, for a total of 8 weeks.

  5. alanine aminotransferase

    The reference range is 0-40 U/L.

    Measured: Measured once a week, for a total of 8 weeks.

  6. aspartate aminotransferase

    The reference range is 0-40 U/L.

    Measured: Measured once a week, for a total of 8 weeks.

  7. urea nitrogen

    Reference range value 3.2-7.1 mmol/L

    Measured: Measured once a week, for a total of 8 weeks.

  8. serum creatinine

    Reference range value: Males 53-106 μmol/L, Females 44-97 μmol/L

    Measured: Measured once a week, for a total of 8 weeks.

  9. electrocardiogram

    During the study period, the P wave, P-R interval, QRS complex, and QT interval of the electrocardiogram will be assessed.

    Measured: Measured once a week, for a total of 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study startSep 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06487117
Sponsor's protocol ID
YJB2024030103
Status last verified
Jun 2024
First submitted
19 Jun 2024
Last updated
5 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Monaghan MG, Borah R, Thomsen C, Browne S. Thou shall not heal: Overcoming the non-healing behaviour of diabetic foot ulcers by engineering the inflammatory microenvironment. Adv Drug Deliv Rev. 2023 Dec;203:115120. doi: 10.1016/j.addr.2023.115120. Epub 2023 Oct 25.

    PubMed 37884128

  • Ibrahim A. IDF Clinical Practice Recommendation on the Diabetic Foot: A guide for healthcare professionals. Diabetes Res Clin Pract. 2017 May;127:285-287. doi: 10.1016/j.diabres.2017.04.013. Epub 2017 Apr 9. No abstract available.

    PubMed 28495183

  • Jupiter DC, Thorud JC, Buckley CJ, Shibuya N. The impact of foot ulceration and amputation on mortality in diabetic patients. I: From ulceration to death, a systematic review. Int Wound J. 2016 Oct;13(5):892-903. doi: 10.1111/iwj.12404. Epub 2015 Jan 20.

    PubMed 25601358

  • Huang YY, Lin CW, Cheng NC, Cazzell SM, Chen HH, Huang KF, Tung KY, Huang HL, Lin PY, Perng CK, Shi B, Liu C, Ma Y, Cao Y, Li Y, Xue Y, Yan L, Li Q, Ning G, Chang SC. Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2122607. doi: 10.1001/jamanetworkopen.2021.22607.

    PubMed 34477854

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Huafu Shengji Ointment and ethacridine lactate solution in people with Diabetic Foot, run by Beijing Daxing District Hospital of Integrated Chinese and Western Medicine.

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 8 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: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ulcer area (time frame: Measured once a week, for a total of 8 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06487117, which also lists 4 linked publications.

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 5 Jul 2024.

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