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

NCT06487117 | Not Yet Recruiting Early Phase 1

• 1 other identifier: YJB2024030103
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Foot

Keywords

Diabetic Foot Ulcer; Huafu Shengji Ointment; Qi Deficiency and Blood Stasis Syndrome; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (4)

• 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 once a week, for a total of 8 weeks.

• 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 once a week, for a total of 8 weeks.

• 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 once a week, for a total of 8 weeks.

• 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.

  complete wound healing (assessed up to 8 weeks)

Secondary Outcomes (9)

• the skin temperature around the wound

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

• the degree of pain

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

• skin color

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

• the extent of wound exudate

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

• alanine aminotransferase

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

Study Arms (2)

Huafu Shengji Ointment

EXPERIMENTAL

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.

Drug: Huafu Shengji Ointment

ethacridine lactate solution

ACTIVE COMPARATOR

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.

Drug: ethacridine lactate solution

Interventions

Huafu Shengji Ointment DRUG

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.

Huafu Shengji Ointment

ethacridine lactate solution DRUG

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.

ethacridine lactate solution

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Daxing District Hospital of Integrated Chinese and Western Medicine: lead
• Beijing University of Chinese Medicine: collaborator

Related Publications (4)

• 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.

  PMID: 37884128 BACKGROUND

• 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.

  PMID: 28495183 BACKGROUND

• 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.

  PMID: 25601358 BACKGROUND

• 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.

  PMID: 34477854 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 5, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-06