Wound HealNCT06272097
Postoperative Wounds With Delayed Healing Risk of Clinical Trial Registration
A study testing Intervention program based on TIME-CDST tool led by wound specialist nurses and A routine wound care program in people with Wound Heal, run by Danni Feng.
Trial summary
this study aims to optimize the components of TIME CDST based on clinical practice and apply the optimized elements to the management of wounds with delayed healing risk after hip arthroplasty to identify and design the key steps in the clinical application of TIME CDST. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- Intervention program based on TIME-CDST tool led by wound specialist nurses and A routine wound care program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years;
- First-time recipient of unilateral total HA or hemiarthroplasty;
- Postoperative wound healing delay risk, defined as epithelialization <50% at 2 weeks postoperatively (quantified using a standardized manual planar measurement method: on day 14 postoperatively, a (quantified using a standardized manual planar measurement method: on day 14 postoperatively, a standardized transparent grid membrane with 1mm² graduations is placed vertically over the wound, and the wound perimeter and epithelialization boundary are marked with a surgical marker. boundary are marked with a surgical marker pen; the epithelialized area is defined as pink, non-exudative tissue completely covering the dermis); Normal cognitive and communication abilities;
- Ability to comply with relevant nursing measures;
- Voluntary participation in this trial
- Voluntary participation in this trial and signed informed consent form.
Who cannot join
- Active infection at the surgical site prior to initial hip surgery; Deep surgical site infection (SSI) or periprosthetic joint infection (PJI) diagnosed or strongly suspected at screening. diagnosed or strongly suspected at screening (based on clinical symptoms, imaging, or aspiration results according to the MSIS/EBJIS criteria);
- Complete wound dehiscence (>2 cm) or exposure of the prosthesis/bone cement, requiring emergency revision surgery;
- Severe vascular insufficiency (ABI <0.5 cm);
- Severe acute and chronic chronic disease (ABI <0.5 cm) insufficiency (ABI <0.6, severe limb ischemia);
- Uncontrolled systemic conditions severely impairing healing potential: severe malnutrition or obesity (BMI≥ 40 kg/m² or≤ 16 kg/m² or serum albumin <2.5 g/dL); Uncontrolled diabetes (HbA1c >9% in the past 3 months); severe heart failure (NYHA IV); severe liver dysfunction (Child-Pugh C); severe renal failure requiring dialysis; active malignant tumors; immunosuppressive therapy (high-dose corticosteroids >10 mg prednisolone); and dose corticosteroids >10 mg prednisone equivalent/day, biologics, or immunosuppressive agents following transplantation).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimization Program for the Care Management of Wounds With Delayed Healing Risk After Hip Arthroplasty Based on TIME CDST Tool: a Randomized Controlled Trial Protocol
this study aims to optimize the components of TIME CDST based on clinical practice and apply the optimized elements to the management of wounds with delayed healing risk after hip arthroplasty to identify and design the key steps in the clinical application of TIME CDST. Through a randomized controlled trial approach, the investigators will conduct a rigorous comparative analysis of the experimental group and the control group. The intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change, while the control group receive a routine wound care program of wound cleaning and dressing changes at each dressing change. The main research objective is to evaluate the superiority of the experimental group compared with the control group in terms of wound healing time, healing quality, and patient satisfaction. Through the implementation of this study, the investigators expect to provide an effective optimization scheme for the management of postoperative wounds with delayed healing risk in clinical practice, thereby improving patient outcomes and quality of life.
Read the detailed description
- Research Background and Objectives Orthopedic surgical wounds present more complex healing challenges compared to other surgical wounds. Hip arthroplasty is the most common type of orthopedic surgery. Due to surgical complexity or patient-specific factors, this procedure is particularly prone to surgical complications such as surgical site infection, wound dehiscence, tissue necrosis, and hematoma, thereby increasing the risk of delayed wound healing postoperatively.To improve the healing outcomes of postoperative wounds with delayed healing, optimizing nursing management protocols is crucial. This study aims to optimize nursing management for wounds with delayed healing risk after hip arthroplasty using the TIME CDST tool and validate its effectiveness.
- Research Methods Study Design: This study employed a randomized controlled trial design, randomly assigning participants to an experimental group and a control group, which received different nursing management protocols. Sample Size: A total of 492 patients are expected to be included, with 246 in the experimental group and 246 in the control group. Intervention Measures: Patients in the experimental group will receive nursing management based on the TIME CDST tool, while those in the control group will receive conventional nursing management. Evaluation Indicators: The primary outcome measure is wound healing time. Secondary outcome measures include the number of cases with wound healing, wound area reduction rate, ASEPSIS wound scoring system, Stone-Brock Scar Scoring Scale (SBSES), Visual Analog Scale (VAS), patient comfort score, patient satisfaction score, albumin levels, dressing change frequency, and medical costs.Clinical adverse events will be recorded for safety assessment. Data collection and analysis: Data will be collected through questionnaire surveys, observation records, statistical analysis, and comparative analysis.
- Study process Screening and grouping: Patients meeting the inclusion criteria will be screened and randomly assigned to the experimental group and control group. Intervention Implementation: The experimental group will receive a nursing management plan based on the TIME CDST tool, while the control group will receive routine nursing management. Follow-up and Evaluation: Regularly assess patients' wound conditions, record healing status, and collect patient satisfaction data. Data Analysis: Analyze the collected data and compare differences between the experimental group and the control group in terms of various assessment indicators. Result Interpretation and Report Writing: Based on the data analysis results, draw conclusions and write the research report.
- Expected Results Through the implementation of this study, the researchers expect to draw the following conclusions: The nursing management plan based on the TIME CDST tool can significantly shorten the wound healing time after hip replacement surgery. This plan can improve the wound healing rate after hip replacement surgery. This plan can enhance patient satisfaction with nursing services. This plan has practical application and promotion value in clinical practice.
- Significance and Value of the Study This study holds significant importance and value for optimizing nursing management of wounds with delayed healing risk. Through scientific experimental design and rigorous data analysis, researchers can provide effective nursing management strategies for clinical practice, thereby improving patient outcomes and quality of life. Additionally, the findings of this study can serve as a reference and inspiration for other similar studies, contributing to the advancement and development of the nursing management field.
- Conditions
- Wound Heal
- Being tested
- Intervention program based on TIME-CDST tool led by wound specialist nurses, A routine wound care program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention program based on TIME-CDST tool led by wound specialist nursesBehavioural
Based on the TIME CDST tool led by wound specialist nurses, which includes the following five areas: A. Assess patient, well-being and wound; B. Bring in multidisciplinary team and informal carers to promote holistic patient care; C. Control or treat underlying causes and barriers to wound healing; D. Decide appropriate treatment; E. Evaluate and reassess the treatment and wound management outcomes; Give patients health education on wound care management.
A routine wound care programBehavioural
A routine wound care program of wound cleaning and dressing changes
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change. Receives: Behavioral: Intervention program based on TIME-CDST tool led by wound specialist nurses |
| Control group | Other | The control group receives a routine wound care program of wound cleaning and dressing changes at each dressing change. Receives: Behavioral: A routine wound care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing time
Wound healing time will be assessed as the primary outcome indicator. Complete epithelialization of the wound is considered as wound healing and the time taken from enrollment to complete wound healing will be recorded for both groups.
Measured: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Secondary outcomes (10)
Number of cases with wound healing
The number of cases in which the wound will be completely epithelialized (defined as pink, non-exudative tissue completely covered by epithelium) during the period from enrollment to the endpoint
Measured: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
The rate of wound area reduction
The rate of wound area reduction will be calculated through the following expression: (original wound area - present wound area)/original wound area × 100%. The accuracy of wound area measurements can be improved by placing a uniform wound measuring tape on one side of the wound and taking a picture of the wound area using image processing and analysis with Image J software (National Institutes of Health, Bethesda, MD).
Measured: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
ASEPSIS wound scoring system
The ASEPSIS wound scoring system will be used to assess surgical wound infection and healing. This evaluation criteria primarily evaluates multiple aspects including wound characteristics, antibiotic use, wound drainage, local debridement, bacterial culture, hospital stay, and home care of the wound. A higher score indicates more severe wound infection. (Total score: 0 to 10 indicates satisfactory healing; 11 to 20 indicates poor healing; 21 to 30 indicates mild wound infection; 31 to 40 indicates moderate wound infection; and greater than 40 indicates severe wound infection.)
Measured: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Stony Brook Scar Evaluation Scale (SBSES)
The Stony Brook Scar Evaluation Scale (SBSES) will be measured the aesthetic outcome of postoperative wounds, including five criteria: width, height, color, suture line, and overall appearance. Each criterion is scored as 0 or 1, with a total score ranging from 0 (worst) to 5 (best)
Measured: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
The pain intensity
The pain intensity is evaluated using the visual analogue scale (VAS). In the absence of pain, a score of 0 represents a painless state; a score of 1 to 3 represents mild pain; a score of 4 to 6 represents moderate pain; and a score of 7 to 10 represents severe pain.
Measured: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Patient comfort score
Use a self-made nursing comfort questionnaire to evaluate the patient's nursing comfort. The questionnaire was conducted on a 10 point scale, with scores>9 indicating extreme comfort, 8-9 indicating relative comfort, 6-7 indicating basic comfort, and<6 indicating discomfort.
Measured: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Patient satisfaction score
Use a self-made nursing satisfaction questionnaire to evaluate the patient's nursing satisfaction. Both questionnaires were conducted on a 10 point scale, with scores>9 indicating very satisfied, 8-9 indicating relative satisfaction, 6-7 indicating basic satisfaction, and<6 indicating dissatisfaction.
Measured: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Albumin levels
Albumin levels
Measured: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
The frequency of dressing changes
The frequency of dressing changes
Measured: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Medical expenses
Medical cost expenditure
Measured: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start31 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danni Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Danni Feng, Tongji Hospital
- Investigators
- Danni Feng, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272097
- Sponsor's protocol ID
- 201328
- Status last verified
- Jul 2025
- First submitted
- 7 Feb 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization Program for the Care Management of Wounds With Delayed Healing Risk After Hip Arthroplasty Based on TIME CDST Tool: a Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT06272097
- Acronym / sponsor ID
- 201328
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- Danni FengUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study aims to optimize the components of TIME CDST based on clinical practice and apply the optimized elements to the management of wounds with delayed healing risk after hip arthroplasty to identify and design the key steps in the clinical application of TIME CDST. Through a randomized controlled trial approach, the investigators will conduct a rigorous comparative analysis of the experimental group and the control group. The intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change, while the control group receive a routine wound care program of wound cleaning and dressing changes at each dressing change. The main research objective is to evaluate the superiority of the experimental group compared with the control group in terms of wound healing time, healing quality, and patient satisfaction. Through the implementation of this study, the investigators expect to provide an effective optimization scheme for the management of postoperative wounds with delayed healing risk in clinical practice, thereby improving patient outcomes and quality of life.
Detailed description
- Research Background and Objectives Orthopedic surgical wounds present more complex healing challenges compared to other surgical wounds. Hip arthroplasty is the most common type of orthopedic surgery. Due to surgical complexity or patient-specific factors, this procedure is particularly prone to surgical complications such as surgical site infection, wound dehiscence, tissue necrosis, and hematoma, thereby increasing the risk of delayed wound healing postoperatively.To improve the healing outcomes of postoperative wounds with delayed healing, optimizing nursing management protocols is crucial. This study aims to optimize nursing management for wounds with delayed healing risk after hip arthroplasty using the TIME CDST tool and validate its effectiveness.
- Research Methods Study Design: This study employed a randomized controlled trial design, randomly assigning participants to an experimental group and a control group, which received different nursing management protocols. Sample Size: A total of 492 patients are expected to be included, with 246 in the experimental group and 246 in the control group. Intervention Measures: Patients in the experimental group will receive nursing management based on the TIME CDST tool, while those in the control group will receive conventional nursing management. Evaluation Indicators: The primary outcome measure is wound healing time. Secondary outcome measures include the number of cases with wound healing, wound area reduction rate, ASEPSIS wound scoring system, Stone-Brock Scar Scoring Scale (SBSES), Visual Analog Scale (VAS), patient comfort score, patient satisfaction score, albumin levels, dressing change frequency, and medical costs.Clinical adverse events will be recorded for safety assessment. Data collection and analysis: Data will be collected through questionnaire surveys, observation records, statistical analysis, and comparative analysis.
- Study process Screening and grouping: Patients meeting the inclusion criteria will be screened and randomly assigned to the experimental group and control group. Intervention Implementation: The experimental group will receive a nursing management plan based on the TIME CDST tool, while the control group will receive routine nursing management. Follow-up and Evaluation: Regularly assess patients' wound conditions, record healing status, and collect patient satisfaction data. Data Analysis: Analyze the collected data and compare differences between the experimental group and the control group in terms of various assessment indicators. Result Interpretation and Report Writing: Based on the data analysis results, draw conclusions and write the research report.
- Expected Results Through the implementation of this study, the researchers expect to draw the following conclusions: The nursing management plan based on the TIME CDST tool can significantly shorten the wound healing time after hip replacement surgery. This plan can improve the wound healing rate after hip replacement surgery. This plan can enhance patient satisfaction with nursing services. This plan has practical application and promotion value in clinical practice.
- Significance and Value of the Study This study holds significant importance and value for optimizing nursing management of wounds with delayed healing risk. Through scientific experimental design and rigorous data analysis, researchers can provide effective nursing management strategies for clinical practice, thereby improving patient outcomes and quality of life. Additionally, the findings of this study can serve as a reference and inspiration for other similar studies, contributing to the advancement and development of the nursing management field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention program based on TIME-CDST tool led by wound specialist nursesThe intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change. |
| Control group | Other | Behavioral: A routine wound care programThe control group receives a routine wound care program of wound cleaning and dressing changes at each dressing change. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥18 years;
- First-time recipient of unilateral total HA or hemiarthroplasty;
- Postoperative wound healing delay risk, defined as epithelialization <50% at 2 weeks postoperatively (quantified using a standardized manual planar measurement method: on day 14 postoperatively, a (quantified using a standardized manual planar measurement method: on day 14 postoperatively, a standardized transparent grid membrane with 1mm² graduations is placed vertically over the wound, and the wound perimeter and epithelialization boundary are marked with a surgical marker. boundary are marked with a surgical marker pen; the epithelialized area is defined as pink, non-exudative tissue completely covering the dermis); Normal cognitive and communication abilities;
- Ability to comply with relevant nursing measures;
- Voluntary participation in this trial
Key exclusion criteria (5 listed)
- Active infection at the surgical site prior to initial hip surgery; Deep surgical site infection (SSI) or periprosthetic joint infection (PJI) diagnosed or strongly suspected at screening. diagnosed or strongly suspected at screening (based on clinical symptoms, imaging, or aspiration results according to the MSIS/EBJIS criteria);
- Complete wound dehiscence (>2 cm) or exposure of the prosthesis/bone cement, requiring emergency revision surgery;
- Severe vascular insufficiency (ABI <0.5 cm);
- Severe acute and chronic chronic disease (ABI <0.5 cm) insufficiency (ABI <0.6, severe limb ischemia);
- Uncontrolled systemic conditions severely impairing healing potential: severe malnutrition or obesity (BMI≥ 40 kg/m² or≤ 16 kg/m² or serum albumin <2.5 g/dL); Uncontrolled diabetes (HbA1c >9% in the past 3 months); severe heart failure (NYHA IV); severe liver dysfunction (Child-Pugh C); severe renal failure requiring dialysis; active malignant tumors; immunosuppressive therapy (high-dose corticosteroids >10 mg prednisolone); and dose corticosteroids >10 mg prednisone equivalent/day, biologics, or immunosuppressive agents following transplantation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention program based on TIME-CDST tool led by wound specialist nursesBased on the TIME CDST tool led by wound specialist nurses, which includes the following five areas: A. Assess patient, well-being and wound; B. Bring in multidisciplinary team and informal carers to promote holistic patient care; C. Control or treat underlying causes and barriers to wound healing; D. Decide appropriate treatment; E. Evaluate and reassess the treatment and wound management outcomes; Give patients health education on wound care management. | Behavioural | Intervention group |
| A routine wound care programA routine wound care program of wound cleaning and dressing changes | Behavioural | Control group |
Primary outcome
Wound healing time
Time frame: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Wound healing time will be assessed as the primary outcome indicator. Complete epithelialization of the wound is considered as wound healing and the time taken from enrollment to complete wound healing will be recorded for both groups.
10 secondary outcomes
Number of cases with wound healing
Time frame: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
The rate of wound area reduction
Time frame: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
ASEPSIS wound scoring system
Time frame: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Stony Brook Scar Evaluation Scale (SBSES)
Time frame: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
The pain intensity
Time frame: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Patient comfort score
Time frame: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Patient satisfaction score
Time frame: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Albumin levels
Time frame: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
The frequency of dressing changes
Time frame: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Medical expenses
Time frame: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danni Feng principal investigator
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Intervention program based on TIME-CDST tool led by wound specialist nurses and A routine wound care program in people with Wound Heal, run by Danni Feng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danni Feng (0086-13476022370, 992911819@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing time (time frame: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.