Low Concentration ALA-PDT in Treatment of Skin Ulcer

Skin Ulcer Clinical Trial

Official title:

Clinical Study of Low Concentration ALA-PDT in Treatment of Skin Ulcer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04689243
• Other study ID #: 2018QN02
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2020
• Source: Sichuan Provincial People's Hospital
• Contact: Yujie Mao, M.D.
• Phone: (86)02887393999
• Email: yujiemao[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 30, 2020
• Est. primary completion date: December 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Photodynamic Therapy
• Skin Ulcer
• Ulcer

Intervention

Procedure:
• ALA-PDT
Low concentration ALA-PDT, 3 times a week.
• red light
red light, 3 times a week.

Locations

Country	Name	City	State
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ulcer area size	The ulcer area size was measured	Change from Baseline ulcer area size at 24 hours after the last treatment.
Secondary	total bacterial load	Levels of total bacteria were tested	Change from Baseline total bacterial load at 24 hours after the last treatment.