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Low Concentration ALA-PDT in Treatment of Skin Ulcer

S

Sichuan Provincial People's Hospital

Status

Unknown

Conditions

Photodynamic Therapy
Skin Ulcer

Treatments

Procedure: red light
Procedure: ALA-PDT

Study type

Interventional

Funder types

Other

Identifiers

NCT04689243
2018QN02

Details and patient eligibility

About

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.

Enrollment

28 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

28 participants in 2 patient groups

ALA-PDT
Experimental group
Treatment:
Procedure: ALA-PDT
red light
Other group
Treatment:
Procedure: red light

Trial contacts and locations

1

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Central trial contact

Yujie Mao, M.D.

Data sourced from clinicaltrials.gov

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