Photon TherapyNCT07383519
Application of Photon Therapy Instrument Combined With Ultrasonic Debridement in Senile Third and Fourth Stage Pressure Injuries
A study testing Photon Therapy Combined with Ultrasonic Debridement Group and Standard Wound Care Group in people with Photon Therapy and Ultrasonic Debridement, run by Dahua Hospital, Xuhui District, Shanghai at 1 site in China.
Trial summary
These findings support the integrated use of ultrasonic debridement and photon therapy as a beneficial treatment strategy for advanced pressure injuries in elderly patients, demonstrating its value in improving both clinical results and overall patient well-being. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Photon Therapy, Ultrasonic Debridement, Combination Therapy
- What is being tested?
- Photon Therapy Combined with Ultrasonic Debridement Group and Standard Wound Care Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 55 years or older
- a patient who is fully conscious (i.e., no disturbance of consciousness such as drowsiness, lethargy, or delirium; able to accurately answer questions about time, place, and person orientation; and capable of clear communication to express needs or understand study-related instructions)
- patients with pressure injury were diagnosed with stage 3 or 4 pressure injury in accordance with the staging criteria of pressure injury published by the National Pressure Injury Advisory Panel (NPUAP).
Who cannot join
- poor blood glucose control (HbA1c > 7.0%)
- patients allergic to red-and-blue light
- mental abnormalities who cannot cooperate with treatment
- patients with advanced malignancies, terminal patients, patients with cachexia, and patients with severe obesity
- severe complications: severe malnutrition, severe diseases of the lungs, liver, kidneys, and cardiovascular system
- patients undergoing other treatments, such as Chinese medicine treatment, negative pressure aspiration therapy, platelet-rich therapy
- who were unwilling to participate in the study. All participants signed a written informed consent form before the study began.
Trial locations and contacts
1 site in 1 country.
China1 site
Dahua Hospital, Xuhui District, Shanghai
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Dahua Hospital, Xuhui District, Shanghai
These findings support the integrated use of ultrasonic debridement and photon therapy as a beneficial treatment strategy for advanced pressure injuries in elderly patients, demonstrating its value in improving both clinical results and overall patient well-being.
Read the detailed description
This study assessed the clinical effectiveness of combining ultrasonic debridement with photon therapy for treating stage 3 and 4 pressure injuries in elderly patients, with particular attention to wound healing, pain reduction, and quality of life outcomes. We enrolled 118 elderly patients with pressure injuries from Shanghai Dahua Hospital between May 1, 2023, and November 30, 2024, using stratified random sampling. Participants were first grouped by injury stage (3 or 4) and then randomly assigned to either control or experimental groups. Control patients received standard moist wound care alongside systemic interventions, whereas the experimental group received the same standard care plus combined ultrasonic debridement and photon therapy. We compared outcomes including wound healing progress, treatment expenses, and pain scores recorded during dressing changes.
- Conditions
- Photon Therapy, Ultrasonic Debridement, Combination Therapy, Geriatric Patients, Pressure Injury
- Being tested
- Photon Therapy Combined with Ultrasonic Debridement Group, Standard Wound Care Group
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon Therapy Combined with Ultrasonic Debridement GroupOther
Participants in this arm received the combined intervention of ultrasonic debridement followed by photon therapy in addition to standard moist wound care and systemic management. Ultrasonic debridement was performed using a handheld device held at a 45-degree angle approximately 0.5 cm from the wound surface to selectively remove necrotic tissue. Subsequently, photon therapy was administered with the light source positioned 10 cm from the wound for 15 minutes per session, using blue light (for infected wounds) followed by red light as indicated. This combined physical therapy regimen aimed to enhance wound bed preparation, reduce bacterial load, promote tissue repair, and accelerate healing in elderly patients with stage 3 or 4 pressure injuries.
Standard Wound Care GroupOther
Participants in this arm received standard moist wound care guided by the TIME principle (Tissue management, Infection/inflammation control, Moisture balance, and Edge advancement) and systemic interventions. Wounds were cleansed with 0.9% normal saline, and appropriate dressings were selected based on wound stage and exudate level. Dressing change frequency was determined according to clinical need. Systemic factors affecting wound healing were addressed, and comprehensive health education was provided, including guidance on repositioning, nutrition, and home care. This arm served as the control to evaluate the added benefit of the combined physical therapy intervention.
| Study group | Role | What they receive |
|---|---|---|
| Photon Therapy Combined with Ultrasonic Debridement Group | Other | Participants in this arm received the combined intervention of ultrasonic debridement followed by photon therapy in addition to standard moist wound care and systemic management. Ultrasonic debridement was performed using a handheld device held at a 45-degree angle approximately 0.5 cm from the wound surface to selectively remove necrotic tissue. Subsequently, photon therapy was administered with the light source positioned 10 cm from the wound for 15 minutes per session, using blue light (for infected wounds) followed by red light as indicated. This combined physical therapy regimen aimed to enhance wound bed preparation, reduce bacterial load, promote tissue repair, and accelerate healing in elderly patients with stage 3 or 4 pressure injuries. Receives: Other: Photon Therapy Combined with Ultrasonic Debridement Group |
| Standard Wound Care Grou | Other | Participants in this arm received standard moist wound care guided by the TIME principle (Tissue management, Infection/inflammation control, Moisture balance, and Edge advancement) and systemic interventions. Wounds were cleansed with 0.9% normal saline, and appropriate dressings were selected based on wound stage and exudate level. Dressing change frequency was determined according to clinical need. Systemic factors affecting wound healing were addressed, and comprehensive health education was provided, including guidance on repositioning, nutrition, and home care. This arm served as the control to evaluate the added benefit of the combined physical therapy intervention. Receives: Other: Standard Wound Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Complete Wound Healing
The primary outcome is the proportion of participants achieving complete wound healing, defined as a Pressure Ulcer Scale for Healing (PUSH) score of 0. The PUSH tool assesses wound area, exudate amount, and tissue type, with a total score range of 0-17.
Measured: Assessed at 6 months post-randomization.
Secondary outcomes (3)
Change in Pain Intensity During Dressing Changes
Mean change in pain scores measured using the Numeric Pain Intensity Scale (NPIS, 0-10) during dressing changes. Scores are recorded at enrollment and 1 month post-intervention.
Measured: Baseline and 1 month post-intervention.
Total Direct Medical Cost of Treatment
The total direct medical costs (in CNY) associated with pressure injury treatment per participant, including materials, procedures, and related care, calculated over the 6-month study period.
Measured: From randomization to 6 months post-intervention.
Change in Wound Severity as Measured by the Pressure Ulcer Scale for Healing (PUSH) Score
Mean change in PUSH scores from baseline to 1, 3, and 6 months post-intervention. A reduction in score indicates wound improvement.
Measured: Baseline, 1 month, 3 months, and 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 May 2023
- Primary completion30 Jul 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photon TherapyStudies 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
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dahua Hospital, Xuhui District, Shanghai
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jie Zeng, Dahua Hospital, Xuhui District, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383519
- Sponsor's protocol ID
- 20220603
- Status last verified
- May 2023
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dahua Hospital, Xuhui District, Shanghai
- ClinicalTrials.gov ID
- NCT07383519
- Acronym / sponsor ID
- 20220603
- Conditions
- Photon Therapy, Ultrasonic Debridement, Combination Therapy, Geriatric Patients, Pressure Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Dahua Hospital, Xuhui District, ShanghaiOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 3 Feb 2026 (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.
These findings support the integrated use of ultrasonic debridement and photon therapy as a beneficial treatment strategy for advanced pressure injuries in elderly patients, demonstrating its value in improving both clinical results and overall patient well-being.
Detailed description
This study assessed the clinical effectiveness of combining ultrasonic debridement with photon therapy for treating stage 3 and 4 pressure injuries in elderly patients, with particular attention to wound healing, pain reduction, and quality of life outcomes. We enrolled 118 elderly patients with pressure injuries from Shanghai Dahua Hospital between May 1, 2023, and November 30, 2024, using stratified random sampling. Participants were first grouped by injury stage (3 or 4) and then randomly assigned to either control or experimental groups. Control patients received standard moist wound care alongside systemic interventions, whereas the experimental group received the same standard care plus combined ultrasonic debridement and photon therapy. We compared outcomes including wound healing progress, treatment expenses, and pain scores recorded during dressing changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photon Therapy Combined with Ultrasonic Debridement Group | Other | Other: Photon Therapy Combined with Ultrasonic Debridement GroupParticipants in this arm received the combined intervention of ultrasonic debridement followed by photon therapy in addition to standard moist wound care and systemic management. Ultrasonic debridement was performed using a handheld device held at a 45-degree angle approximately 0.5 cm from the wound surface to selectively remove necrotic tissue. Subsequently, photon therapy was administered with the light source positioned 10 cm from the wound for 15 minutes per session, using blue light (for infected wounds) followed by red light as indicated. This combined physical therapy regimen aimed to enhance wound bed preparation, reduce bacterial load, promote tissue repair, and accelerate healing in elderly patients with stage 3 or 4 pressure injuries. |
| Standard Wound Care Grou | Other | Other: Standard Wound Care GroupParticipants in this arm received standard moist wound care guided by the TIME principle (Tissue management, Infection/inflammation control, Moisture balance, and Edge advancement) and systemic interventions. Wounds were cleansed with 0.9% normal saline, and appropriate dressings were selected based on wound stage and exudate level. Dressing change frequency was determined according to clinical need. Systemic factors affecting wound healing were addressed, and comprehensive health education was provided, including guidance on repositioning, nutrition, and home care. This arm served as the control to evaluate the added benefit of the combined physical therapy intervention. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 55 years or older
- a patient who is fully conscious (i.e., no disturbance of consciousness such as drowsiness, lethargy, or delirium; able to accurately answer questions about time, place, and person orientation; and capable of clear communication to express needs or understand study-related instructions)
- patients with pressure injury were diagnosed with stage 3 or 4 pressure injury in accordance with the staging criteria of pressure injury published by the National Pressure Injury Advisory Panel (NPUAP).
Key exclusion criteria (7 listed)
- poor blood glucose control (HbA1c > 7.0%)
- patients allergic to red-and-blue light
- mental abnormalities who cannot cooperate with treatment
- patients with advanced malignancies, terminal patients, patients with cachexia, and patients with severe obesity
- severe complications: severe malnutrition, severe diseases of the lungs, liver, kidneys, and cardiovascular system
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 |
|---|---|---|
| Photon Therapy Combined with Ultrasonic Debridement GroupParticipants in this arm received the combined intervention of ultrasonic debridement followed by photon therapy in addition to standard moist wound care and systemic management. Ultrasonic debridement was performed using a handheld device held at a 45-degree angle approximately 0.5 cm from the wound surface to selectively remove necrotic tissue. Subsequently, photon therapy was administered with the light source positioned 10 cm from the wound for 15 minutes per session, using blue light (for infected wounds) followed by red light as indicated. This combined physical therapy regimen aimed to enhance wound bed preparation, reduce bacterial load, promote tissue repair, and accelerate healing in elderly patients with stage 3 or 4 pressure injuries. | Other | Photon Therapy Combined with Ultrasonic Debridement Group |
| Standard Wound Care GroupParticipants in this arm received standard moist wound care guided by the TIME principle (Tissue management, Infection/inflammation control, Moisture balance, and Edge advancement) and systemic interventions. Wounds were cleansed with 0.9% normal saline, and appropriate dressings were selected based on wound stage and exudate level. Dressing change frequency was determined according to clinical need. Systemic factors affecting wound healing were addressed, and comprehensive health education was provided, including guidance on repositioning, nutrition, and home care. This arm served as the control to evaluate the added benefit of the combined physical therapy intervention. | Other | Standard Wound Care Grou |
Primary outcome
Proportion of Participants with Complete Wound Healing
Time frame: Assessed at 6 months post-randomization.
The primary outcome is the proportion of participants achieving complete wound healing, defined as a Pressure Ulcer Scale for Healing (PUSH) score of 0. The PUSH tool assesses wound area, exudate amount, and tissue type, with a total score range of 0-17.
3 secondary outcomes
Change in Pain Intensity During Dressing Changes
Time frame: Baseline and 1 month post-intervention.
Total Direct Medical Cost of Treatment
Time frame: From randomization to 6 months post-intervention.
Change in Wound Severity as Measured by the Pressure Ulcer Scale for Healing (PUSH) Score
Time frame: Baseline, 1 month, 3 months, and 6 months post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photon Therapy Combined with Ultrasonic Debridement Group and Standard Wound Care Group in people with Photon Therapy and Ultrasonic Debridement, run by Dahua Hospital, Xuhui District, Shanghai at 1 site in China.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Complete Wound Healing (time frame: Assessed at 6 months post-randomization.). 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 3 Feb 2026.