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NCT Number: NCT07383519

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

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.

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Key information

Conditions

Photon Therapy Combination Therapy Geriatric Patients Pressure Injury Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Ultrasonic Debridement

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dahua Hospital, Xuhui District, Shanghai

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard Wound Care Group

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dahua Hospital, Xuhui District, Shanghai

Other Gov

Registry information

Official study title

Dahua Hospital, Xuhui District, Shanghai

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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