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

NCT07383519 | Completed

• 1 other identifier: 20220603
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Injury; Photon Therapy; Ultrasonic Debridement; Combination Therapy; Geriatric Patients

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed at 6 months post-randomization.

Secondary Outcomes (3)

• Change in Pain Intensity During Dressing Changes

  Baseline and 1 month post-intervention.

• Total Direct Medical Cost of Treatment

  From randomization to 6 months post-intervention.

• Change in Wound Severity as Measured by the Pressure Ulcer Scale for Healing (PUSH) Score

  Baseline, 1 month, 3 months, and 6 months post-intervention.

Other Outcomes (1)

• Complete Healing Rate Stratified by Pressure Injury Stage

  3 months and 6 months post-intervention.

Study Arms (2)

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.

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.

Other: Standard Wound Care Group

Interventions

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.

Photon Therapy Combined with Ultrasonic Debridement Group

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.

Standard Wound Care Grou

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dahua Hospital, Xuhui District, Shanghai: lead

Study Sites (1)

Dahua Hospital, Xuhui District, Shanghai

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dahua Hospital, Xuhui District, Shanghai

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: May 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 3, 2026

Record last verified: 2023-05

Locations

CN (1)