Clinical efficacy and mechanism of Shang-Ke-Huang-Shui in the treatment of diabetic foot ulcers

Clinical trial on treatment of diabetic foot ulcers by Shang-Ke-Huang-Shui

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400084491

Enrollment

Unknown

Registered

2024-05-17

Start date

2024-05-22

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic foot ulcers

Interventions

treatment group:Basic treatment + Topical application of Shang-Ke-Huang-Shui

Control group:Basic treatment + Topical application of An'erdian skin antiseptic III

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) It meets the diagnostic criteria of diabetes and diabetic foot in Western medicine and belongs to the period of deswelling and deputrification in traditional Chinese medicine. (2) DFUs classification belongs to Wanger classification level 2 to 3. (3) The wound area of DFUs after debridement was 1-25 cm2. (4) DFUs present for at least 4 weeks. (5) HbA1c 18 years old, gender unlimited. (7) The patients signed informed consent and volunteered to participate in the study.

Exclusion criteria

Exclusion criteria: (1) The patient has developed severe local gangrene requiring amputation, or with dry gangrene on admission. (2) Patients with hereditary, infectious diseases, malignant tumors, or severe malnutrition. (3) The patient had serious heart, liver, renal insufficiency and systemic infection. (4) Pregnant or lactating women. (5) Patients suffering from severe malnutrition, mental disorders, alcoholism or drug abuse. (6) Patients who have participated in other clinical trials within the last 4 weeks. (7) Ulcer area was reduced by more than 30% between the screening visit and baseline visit (about 1 week).

Design outcomes

Primary

Measure	Time frame
The proportion of people whose wounds have fully healed by the end of treatment;;The time it takes for the ulcer to heal completely;;The duration of DFUs from the detumescence and deputrification period to deputrification and tissue regeneration period;Levels of inflammatory cytokines in DFUs tissues (including IL-1ß, IL-18, IL-6, IL-10, TNF-a, MCP-1, and hsCRP );TCM syndrome score (including Redness, swelling, heat, pain, pus, foot numbness score, intermittent claudication, Fuyang pulse movement );	—

Measure

Time frame

The proportion of people whose wounds have fully healed by the end of treatment;;The time it takes for the ulcer to heal completely;;The duration of DFUs from the detumescence and deputrification period to deputrification and tissue regeneration period;Levels of inflammatory cytokines in DFUs tissues (including IL-1ß, IL-18, IL-6, IL-10, TNF-a, MCP-1, and hsCRP );TCM syndrome score (including Redness, swelling, heat, pain, pus, foot numbness score, intermittent claudication, Fuyang pulse movement );

—

Secondary

Measure	Time frame
Ulcer area reduction rate per week;;The median healing time of wounds reached 50% and 100% area;Peroneotibial nerve conduction velocity;Ankle-brachial index, ABI;Percutaneous partial pressure of oxygen, TcPO2;	—

Countries

China

Contacts

Public ContactKaijun Lei, Wei Ke

Foshan Hospital of Traditional Chinese Medicine

leikj@fshtcm.com.cn+86 757 8109 2312

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026