An observational study in Bedsores, sponsored by Tianjin University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Tianjin University of Traditional Chinese Medicine · Observational
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.
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's planned enrollment of 500 is above the median of 138 across 110 observational studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Tianjin University of Traditional Chinese Medicine is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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.
Time frame: 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.
Time frame: Weekly assessments up to the end of follow-up (8 weeks)
Visual Analog Scale (VAS) for Pain
Pain levels will be assessed and compared between the two groups of patients with pressure injuries using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, with lower scores indicating reduced pain intensity. 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.
Time frame: 8weeks
Pressure Ulcer Scale for Healing (PUSH)
Wound healing status will be assessed and compared between the two groups using the Pressure Ulcer Scale for Healing (PUSH). The scale evaluates three dimensions-wound area, exudate amount, and tissue type-with a total score ranging from 0 to 17 points; lower scores indicate better healing. Assessments will be performed weekly from the start of treatment until the end of follow-up.
Time frame: 8weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
Of 49 observational studies under Pressure Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 141. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Tianjin University of Traditional Chinese Medicine