Jingwanhong for Bedsores

NCT07761078 | Not Yet Recruiting DMC

• 1 other identifier: 25JCLZJC00170
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn whether Jingwanhong Ointment (a compound traditional Chinese medicine preparation) can effectively and safely treat pressure injuries (bedsores) in long-term bedridden patients in a real-world clinical setting. The main questions it aims to answer are: Does treatment with Jingwanhong Ointment improve healing outcomes of pressure injuries in long-term bedridden patients? Is Jingwanhong Ointment safe for use in this patient population? Do patients with different Traditional Chinese Medicine (TCM) syndrome patterns (Qi Stagnation and Blood Stasis, Toxin Accumulation with Rotting Ulceration, and Qi-Blood Deficiency) respond differently to treatment, and which subgroups benefit most? Researchers will use propensity score matching (PSM) and Cox proportional hazards models to control for confounding factors, and will stratify patients by TCM syndrome pattern to explore treatment response and identify patient subgroups most likely to benefit from Jingwanhong Ointment. Participants who are long-term bedridden and diagnosed with pressure injuries will be enrolled in a prospective, multicenter, real-world cohort at approximately 500 . Participants will:Receive standardized treatment with Jingwanhong Ointment as part of their routine clinical care for pressure injuries. Be followed over time to assess wound healing outcomes, safety, and treatment response according to their TCM syndrome classification.

Conditions

Bedsores

Outcome Measures

Primary Outcomes (2)

• Healing Time (from intervention to complete epithelialization of the wound)

  Healing time is defined as the time from initiation of wound treatment to complete epithelialization of the wound surface. This outcome is determined by visual inspection: the wound is considered epithelialized when it is completely covered by epithelial tissue with no obvious exudate or tenderness/inflammatory signs. The time from treatment initiation to complete epithelialization is recorded as the healing time. This measure reflects the speed and efficiency of wound healing. The wound will be assessed daily, and the date of first complete epithelialization will be recorded. If the wound heals completely within 4 weeks, follow-up will be terminated early and the actual healing time recorded; if not healed, observation will continue until the study endpoint at 8 weeks.

  8weeks

• Complete Wound Healing Rate

  The original wound area is first recorded, typically by tracing the wound outline on a transparent film and calculating the area. After treatment, the remaining unhealed wound area is similarly measured using transparent film tracing and area calculation. The wound healing rate is then calculated using the formula: Wound Healing Rate = (Original Wound Area - Unhealed Wound Area) / Original Wound Area × 100%. This measure provides a direct reflection of the degree of wound healing after 4 weeks of treatment. Assessments will be performed weekly from the start of treatment until the end of follow-up.

  Weekly assessments up to the end of follow-up (8 weeks)

Secondary Outcomes (2)

• Visual Analog Scale (VAS) for Pain

  8weeks

• Pressure Ulcer Scale for Healing (PUSH)

  8weeks

Study Arms (2)

Exposed Cohort: Jingwanhong Ointment

Participants in this cohort are defined as long-term bedridden patients with pressure injuries who receive treatment with Jingwanhong Ointment. Product specification: Jingwanhong Ointment, manufactured by Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. Dosage and administration: The wound surface is first cleansed with normal saline. An appropriate amount of Jingwanhong Ointment is then applied directly to the wound, or spread onto sterile gauze, which is placed over the wound and covered with a sterile dressing. Dressings are changed once daily.

Drug: Jingwanhong Ointment

Non-Exposed Cohort: Standard Care only

Participants in this cohort are defined as long-term bedridden patients with pressure injuries who do not receive treatment with Jingwanhong Ointment. These participants receive standard wound care per routine clinical practice at the study site, without the use of Jingwanhong Ointment.

Interventions

Jingwanhong Ointment DRUG

A topical compound traditional Chinese medicine ointment composed of multiple herbal ingredients, applied externally to the wound surface to promote tissue repair and wound healing in patients with pressure injuries.

Also known as: Jingwanhong Ruangao

Exposed Cohort: Jingwanhong Ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll long-term bedridden patients aged over 18 years with an expected survival of at least 3 months and an anticipated bed rest duration exceeding 1 month. Eligible participants must have a clinically diagnosed pressure injury (Stage I-IV), based on the diagnostic and staging criteria from the NPUAP/EPUAP/PPPIA Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline (2019). Patients will additionally be classified by traditional Chinese medicine (TCM) syndrome type-Qi Stagnation and Blood Stasis, Toxin Accumulation with Putrefaction, or Qi-Blood Deficiency-according to the 2019 guideline issued by the China Association of Chinese Medicine. All participants must voluntarily agree to join the study and provide signed informed consent. Patients will be excluded if they have a known allergy or hypersensitivity to any component of Jingwanhong Ointment, have a diagnosed psychiatric disorder, present with a wound showing malignant transformation or

You may qualify if:

• Age \> 18 years
• Expected survival ≥ 3 months
• Long-term bedridden patients with an anticipated bed rest duration exceeding 1 month.
• Clinically diagnosed with pressure injury (Stage I-IV), based on the diagnostic and staging criteria defined in the Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline (2019), jointly developed by the National Pressure Ulcer Advisory Panel (NPUAP), the European Pressure Ulcer Advisory Panel (EPUAP), and the Pan Pacific Pressure Injury Alliance (PPPIA). TCM syndrome differentiation will be based on the Clinical Diagnosis and Treatment Guideline for Bedsores in Traditional Chinese Medicine Surgery, issued by the China Association of Chinese Medicine in January 2019, classifying patients into three syndrome types: Qi Stagnation and Blood Stasis, Toxin Accumulation with Putrefaction, and Qi-Blood Deficiency
• Willing to participate in the study and provide signed informed consent

You may not qualify if:

• Known allergy or hypersensitivity to any component of Jingwanhong Ointment
• Diagnosed with a psychiatric disorder
• Wound with malignant transformation or fistula formation
• Currently participating in another clinical trial

Sponsors & Collaborators

• Tianjin University of Traditional Chinese Medicine: lead
• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: collaborator

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Tianyi Zhao M.D.

CONTACT

+8613820642091; zhaotianyi89@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tianyi Zhao,M.D.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08