Low Concentration ALA-PDT in Treatment of Skin Ulcer

Not Applicable

• Conditions: Skin Ulcer; Photodynamic Therapy
• Interventions: Procedure: red light; Procedure: ALA-PDT

• Registration Number: NCT04689243
• Lead Sponsor: Sichuan Provincial People's Hospital

Brief Summary

Skin ulcer is a common disease with complicated etiopathogenes, which makes it hard to be cured. It has been reported that photodynamic therapy (PDT) can be used to treat skin ulcers which were caused by different diseases. However, PDT is an expensive treatment and patients always experience obvious pain during or after the treatment, which hinders the application of PDT in skin ulcer. Our previous study found that PDT using a low concentration of 5-Aminolevulinic acid (ALA) could promote the healing of skin ulcer without obvious adverse reactions, which suggests us that low concentration ALA-PDT might be an efficient and cost effective treatment in skin ulcer. To further investigate the use of low concentration ALA-PDT in skin ulcer, we plan to recruit patients with skin ulcers caused by different diseases, and divide these patients into different groups according to their causes of disease, and then treat them using low concentration ALA-PDT to observe the healing process of skin ulcer. This study could further optimize and promote the use of low concentration ALA-PDT in skin ulcer.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-23
• Primary Completion: 2020-12-26
• Study First Submitted QC: 2020-12-29
• Last Update Submitted: 2020-12-29
• Study Completion: 2020-12-30
• Study First Posted: 2020-12-30
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• chronic skin wounds that involved the dermis and did not heal in three months or did not exhibit a tendency toward healing

Exclusion Criteria

• allergies to photosensitizers and their solvents, serious medical illnesses, such as severe heart disease, severe liver or kidney dysfunction, systemic infection or any concomitant infection that would require treatment with an additional antimicrobial agent, the use of topical or systemic antibiotics within one month prior to treatment. Pregnant or lactating women were also excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
red light	red light	-
ALA-PDT	ALA-PDT	-

Primary Outcome Measures

Name	Time	Method
ulcer area size	Change from Baseline ulcer area size at 24 hours after the last treatment.	The ulcer area size was measured

Secondary Outcome Measures

Name	Time	Method
total bacterial load	Change from Baseline total bacterial load at 24 hours after the last treatment.	Levels of total bacteria were tested

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China