Application of Photon Therapy Instrument Combined With Ultrasonic Debridement in Senile Third and Fourth Stage Pressure Injuries

January 26, 2026 updated by: Jie Zeng, Dahua Hospital, Xuhui District, Shanghai

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200031
        • Dahua Hospital, Xuhui District, Shanghai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Photon Therapy Combined with Ultrasonic Debridement Group
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.
Other: Photon Therapy Combined with Ultrasonic Debridement Group
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.
Other: Standard Wound Care Grou
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.
Other: Standard Wound Care Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Assessed at 6 months post-randomization.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity During Dressing Changes
Time Frame: Baseline and 1 month post-intervention.
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.
Baseline and 1 month post-intervention.
Total Direct Medical Cost of Treatment
Time Frame: From randomization to 6 months post-intervention.
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.
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.
Mean change in PUSH scores from baseline to 1, 3, and 6 months post-intervention. A reduction in score indicates wound improvement.
Baseline, 1 month, 3 months, and 6 months post-intervention.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Healing Rate Stratified by Pressure Injury Stage
Time Frame: 3 months and 6 months post-intervention.
The proportion of participants achieving complete wound healing (PUSH = 0) separately for stage 3 and stage 4 pressure injuries at 3 and 6 months.
3 months and 6 months post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dahua Hospital, Xuhui District, Shanghai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20220603

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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