Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06445699

Investigation of Combination Aminolaevulinic Acid-Photodynamic Therapy and Hydrogel Dressing for Chronic Cutaneous Wounds

Led by Army Medical University, China · Updated on 2024-07-30

69

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying chronic infectious wounds, focusing on how different treatments may affect wound healing. This trial compares three groups of patients with chronic wounds that have not healed after at least three months of conventional treatment. The study aims to evaluate the healing rate, overall effectiveness, patient satisfaction, adverse reactions, and recurrence of wounds using photodynamic therapy (PDT), hydrogel dressing, or their combination. Patients are randomly assigned to one of three groups. Group 1 receives hydrogel dressing changes every three days along with topical mupirocin ointment applied three times daily. Group 2 undergoes four sessions of PDT spaced ten days apart, which involves applying aminolaevulinic acid to the wound, covering it with dark plastic for three hours, then illuminating it with red LED light. Group 3 receives the same PDT treatment as Group 2 followed by hydrogel dressing changes every three days. All treatments start after thorough wound cleaning and debridement to remove dead tissue and foreign bodies. During the study, patient responses and any adverse effects are recorded. Follow-up visits occur at 2, 4, 8, and 12 weeks after treatment ends to monitor wound healing and assess patient satisfaction. Researchers measure the wound healing rate, total effectiveness, and patient satisfaction up to 12 weeks post-treatment. The trial runs from January 2023 to August 2024 and includes adults aged 18 to 70 years with chronic wounds suitable for these treatments.

CONDITIONS

Brief Title

Photodynamic Therapy With Hydrogel Dressing for Chronic Wounds

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with chronic wounds caused by trauma or surgery that have not healed after at least three months of standard medical treatment
  • Patients with stable vital signs who are not taking glucocorticoids, immunosuppressive agents, or anticoagulants during treatment
  • Participants able to provide signed informed consent, comply with the study, participate in follow-up, and cooperate with monitoring adverse events and effectiveness
  • Skin wound diameter must not exceed 10 centimeters
Not Eligible

You will not qualify if you...

  • Allergy to aminolaevulinic acid (ALA)
  • Women who are recently fertile, pregnant, or planning to breastfeed
  • Patients with worsening or deepening wounds or infections
  • Poor compliance preventing completion of treatment
  • Wounds caused by vascular disease, autoimmune diseases, metabolic diseases, or malignant tumors (local or metastatic)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 4 to 6 weeks

Participants receive treatment based on their assigned group: hydrogel dressing changes every 3 days, photodynamic therapy (PDT) every 10 days for 4 sessions, or a combination of PDT and hydrogel dressing changes. Wounds are debrided before treatment, and adverse reactions are monitored throughout.

Hydrogel dressing changes every 3 days and/or PDT visits every 10 days for 4 sessions

Follow-up

Duration - 12 weeks

Participants return for follow-up visits to evaluate wound healing, treatment effectiveness, and satisfaction at scheduled intervals after treatment completion.

4 visits at weeks 2, 4, 8, and 12 after treatment ends

Trial Site Locations

Total: 1 location

1

Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)

Chongqing, Chongqing Municipality, China, 400038

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Research Team

R

Rui Yin, MD, PhD

P

Pan Chen, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Phase IIa randomized, placebo-controlled study of antimicrobial photodynamic therapy in bacterially colonized, chronic leg ulcers and diabetic foot ulcers: a new approach to antimicrobial therapy.

S Morley, J Griffiths, G Philips...

https://pubmed.ncbi.nlm.nih.gov/23066973