Using light therapy and hydrogel dressings to heal chronic wounds

Investigation the Clinical Effectiveness of Combination Topical Aminolaevulinic Acid-Photodynamic Therapy With Hydrogel Dressing for Treatment Chronic Cutaneous Wounds

This study is testing whether using light therapy, hydrogel dressings, or both can help heal chronic wounds in patients with infections.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 69 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Army Medical University, China (other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06445699 on ClinicalTrials.gov

What this trial studies

This clinical trial involves 63 patients with chronic infectious wounds who are randomly assigned to three treatment groups. One group receives hydrogel dressings, another group undergoes photodynamic therapy (PDT), and the third group receives both treatments. The study assesses wound healing rates, patient satisfaction, and any adverse reactions over the treatment period. The methodology includes thorough wound debridement followed by the application of treatments at specified intervals.

Who should consider this trial

Good fit: Ideal candidates are patients with chronic wounds from trauma or surgery that have not healed after three months of traditional treatment.

Not a fit: Patients with allergies to ALA, deepening wounds, or those with certain systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve healing rates for patients with chronic wounds.

How similar studies have performed: Other studies have shown promise with photodynamic therapy for wound healing, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 1\) patients with chronic wounds caused by trauma or surgery who failed to heal after traditional formal medical treatment at least over three months;
* 2\) Patients with stable vital signs who had no systemic medical disease and did not take glucocorticoids, immunosuppressive agents, or anticoagulants during the entire treatment process;
* 3\) Participants provided signed informed consent, were able to comply with the program, were willing to participate in follow-up, and were able to cooperate in the observation of adverse events and efficacy;
* 4\) The diameter of the skin wound should not exceed 10 centimeters.

Exclusion Criteria:

* 1\) Patients are allergic to ALA;
* 2\) Women with recent fertility, pregnancy or lactation plans;
* 3\) Patients with deepening wounds or worsening infections;
* 4\) Poor compliance leading to an inability to complete the treatment in its entirety;
* 5\) Cutaneous ulcer caused by vascular disease, autoimmune diseases, metabolic diseases, local or metastatic malignant tumors.

Where this trial is running

Chongqing, Chongqing Municipality

• Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University) — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Rui Yin, MD, PhD — Southwest Hospital, Third Military Medical University, Chongqing, 400038, China
• Study coordinator: Rui Yin, MD, PhD

Conditions: Photodynamic Therapy, Wound healing, Aminolaevulinic acid, Photodynamic therapy, Hydrogel dressing