Clinical trial NCT06487117: The Efficacy and Safety Assessment of Huafu Shengji Ointment in Patients With Diabetic Foot of Qi Deficiency and Blood Stasis Syndrome
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Diabetic Foot
Keywords: Diabetic Foot Ulcer
Huafu Shengji Ointment
Qi Deficiency and Blood Stasis Syndrome
Randomized Controlled Trial
Lead sponsor: Beijing Daxing District Hospital of Integrated Chinese and Western Medicine
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
First posted: 2024-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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Patients who meet the following criteria will be included:

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

Exclusion Criteria:

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Patients who meet any of the following criteria will be excluded:

1. Patients who experience severe allergic reactions to the experimental medication and cannot undergo treatment.
2. Patients with poorly controlled serious conditions such as diabetic ketoacidosis, ketoacidosis, or diseases of the liver and kidneys.
3. Patients with psychiatric disorders or severe depression.
4. Women who are pregnant or breastfeeding.
5. Patients with severe organic tumors.

Primary outcomes:
measure: ulcer area
timeFrame: Measured once a week, for a total of 8 weeks.
measure: granulation tissue coverage
timeFrame: Measured once a week, for a total of 8 weeks.
measure: ulcer volume
timeFrame: Measured once a week, for a total of 8 weeks.
measure: the time of complete wound healing
timeFrame: complete wound healing (assessed up to 8 weeks)
Secondary outcomes:
measure: the skin temperature around the wound
timeFrame: Measured once a week, for a total of 8 weeks.
measure: the degree of pain
timeFrame: Measured once a week, for a total of 8 weeks.
measure: skin color
timeFrame: Measured once a week, for a total of 8 weeks.
measure: the extent of wound exudate
timeFrame: Measured once a week, for a total of 8 weeks.
measure: alanine aminotransferase
timeFrame: Measured once a week, for a total of 8 weeks.
measure: aspartate aminotransferase
timeFrame: Measured once a week, for a total of 8 weeks.
measure: urea nitrogen
timeFrame: Measured once a week, for a total of 8 weeks.
measure: serum creatinine
timeFrame: Measured once a week, for a total of 8 weeks.
measure: electrocardiogram
timeFrame: Measured once a week, for a total of 8 weeks.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.